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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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The purpose of this global Phase 2 study is to determine the efficacy, safety, and tolerability of 3 dose levels of OG-6219 in pre-menopausal women between 18 and 49 years of age (inclusive), who have moderate to severe endometriosis-related pain.
This is a global multicenter, Phase 2a/b, randomized, double-blind, Placebo-controlled study to assess the efficacy, safety, and tolerability of 3 dose levels of OG-6219, in pre-menopausal women 18 to 49 years of age (inclusive), who have been surgically diagnosed with endometriosis with moderate to severe endometriosis-related pain. This study includes treatment lasting approximately 16 weeks in total and is followed by a Safety Follow-up visit.
Pre-menopausal females aged 18 to 49 years old (inclusive), who have been surgically diagnosed with endometriosis will be screened and randomly assigned to study treatment. A minimum subset of 10 participants per treatment group (including Placebo group) will be voluntarily enrolled for optional intensive PK sampling for the entire duration of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: OG-6219 Dose 1 | Experimental | Group A: OG-6219 Dose 1 BID |
|
| Group B: OG-6219 Dose 2 | Experimental | Group B: OG-6219 Dose 2 BID |
|
| Group C: OG-6219 Dose 3 | Experimental | Group C: OG-6219 Dose 3 BID |
|
| Group D: Placebo | Placebo Comparator | Group D: Placebo BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OG-6219 | Drug | OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Cycle in Mean Overall Pelvic Pain Score at Treatment Cycle 3 | Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dysmenorrhea or NMPP, and dyspareunia. Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. The mean OPP score was derived by the pain score for the dysmenorrhea and NMPP items, and score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. Baseline cycle OPP score was defined as the average daily OPP during baseline cycle. | Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered an investigational product and which does not necessarily have a causal relationship with this treatment. An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. TEAEs were defined as events that first occur or worsen (increase in severity) after the first dose of study drug, during the treatment period, and up to 14 days (inclusive) after the last dose of study drug administration. Percentages are rounded off to the hundredth decimal place. | From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days |
| Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation | An AE was defined as any untoward medical occurrence in a clinical study participant administered an investigational product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as events that first occur or worsen (increase in severity) after the first dose of study drug, during the treatment period, and up to 14 days (inclusive) after the last dose of study drug administration. The TEAEs leading to permanent discontinuation of study drug was identified by using the 'Action taken with study treatment' variable equal to 'Drug withdrawal' from the AE page of the electronic case report form. Percentages are rounded off to the hundredth decimal place. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Cycle in Mean Dysmenorrhea Score at Treatment Cycle 3 | Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dysmenorrhea. Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. The mean dysmenorrhea score was calculated for each cycle as the total of daily dysmenorrhea scores reported during the cycle divided by the number of days during the cycle when a dysmenorrhea score was reported. Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Lead Late-Stage Clinical Development | Organon and Co | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Research Associates LLC dba Flourish Research | Birmingham | Alabama | 35205 | United States | ||
| UAB Center for Women's Reproductive Health |
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 354 participants were randomized and enrolled in the study. Participants were randomized in a 1:1:1:1 ratio at randomization visit (Visit 4) to receive 1 of 3 doses of OG-6219 or matching placebo.
This Phase 2a/b, double-blind, placebo-controlled study was conducted in pre-menopausal women 18 to 49 years of age with moderate to severe endometriosis-related pain (ERP) at 93 centers in 11 countries between 25 October 2022 and 28 May 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matching with OG-6219 orally twice a day (BID) from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| FG001 | OG-6219 50 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 16, 2024 | Feb 5, 2026 |
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| Placebo | Drug | Participants will receive (orally) OG-6219 Placebo tablets BID during treatment cycles. |
|
| From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days |
| Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
| Change From Baseline Cycle in Mean Non-Menstrual Pelvic Pain Score at Treatment Cycle 3 | Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dysmenorrhea. Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. The mean NMPP score was calculated for each cycle as the total of daily NMPP scores reported during the cycle divided by the number of days during the cycle when a NMPP score was reported. Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first. | Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
| Change From Baseline Cycle in Mean Dyspareunia Score at Treatment Cycle 3 | Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dyspareunia. Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. The mean dyspareunia score was calculated for each cycle as the total of dyspareunia scores reported during each cycle divided by the number of days when participants engaged in any sexual activity that involved full vaginal penetration during each cycle (that is, the number of days during the baseline cycle when a dyspareunia score was reported). Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first. | Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
| Change From Baseline Cycle in Mean Number of Rescue Medication Tablets Used for Endometriosis-Related Pain at Treatment Cycles 1, 2 and 3 | Participants were asked daily whether they used the rescue medication in the past 24 hours to treat their ERP. If yes, the number of tablets was documented. The mean number of tablets of rescue medication for ERP was calculated for each cycle as the total number of tablets of rescue medication for ERP reported during the cycle, divided by the number of days during the cycle when a value was reported. Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first. | Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
| Change From Baseline Cycle in Percentage of Days With Participants Used Rescue Medication for Endometriosis-Related Pain at Treatment Cycles 1, 2 and 3 | Participants were asked daily whether they used the rescue medication in the past 24 hours to treat their ERP. If yes, the number of tablets was documented. The percentage of days participant had used rescue medication for ERP was calculated for each cycle as the total number of days participant had used any rescue medication for ERP, divided by the number of days during the cycle when a value was reported. Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first. | Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
| Change From Start of Treatment Cycle 1 in Participants With Patient Global Impression of Severity (PGI-S) to Start of Treatment Cycle 2, End of Treatment Cycles 2 and 3 | The PGI-S was a single item measuring the overall severity of pelvic pain over the past 7 days on a 4-point Likert-type scale (0=None, 1=Mild, 2=Moderate, 3=Severe), score ranged from 0 (none) and 3 (severe), where lower score indicated a better outcome. Treatment Cycle 1 was the period between the first day of menses associated with treatment start (Visit 4) to the day prior to the first day of next menses, regardless of number of days. | Start of Treatment Cycle 1 (Day 1) and start of Treatment Cycle 2 (Day 33), end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
| Percentage of Participants With Any Improvement on the Patient Global Impression of Change (PGI-C) at Start of Treatment Cycle 2 and End of Treatment Cycles 2 and 3 | The PGI-C was a single item measuring the change in pelvic pain since the start of the study drug on a 5-point scale (0=much better, 1=a little better, 2=no change, 3=a little worse, 4=much worse), score ranged from 0 (much better) and 4 (much worse), where lower score indicated a better outcome. Participants with any improvement on the PGI-C were defined as a PGI-C score of 0 or 1 (0=much better and 1=a little better). Treatment Cycle 2 was the period between the first day of menses associated with start of treatment Cycle 2 to the day prior to the first day of next menses, regardless of number of days. | Start of Treatment Cycle 2 (Day 33), end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
| Change From Baseline Cycle in Endometriosis Health Profile-30 (EHP-30) Domains Score at Treatment Cycle 3 | The EHP-30 was a validated disease specific patient-reported outcome instrument measuring the health-related quality of life of women with endometriosis on a 5-point Likert-type scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=always). The EHP-30 consisted of 30 items with following domains: pain (11 items), score ranged from 0 (never) to 44 (always); controls and powerlessness (6 items), score ranged from 0 (never) to 24 (always); emotional well-being (6 items), score ranged from 0 (never) to 24 (always); social support (4 items), score ranged from 0 (never) to 16 (always); and self-image (3 items), score ranged from 0 (never) to 12 (always). Each domain lower score indicated a better outcome. Total EHP-30 score ranged from 0 (never) and 120 (always), where lower score indicated a better outcome. Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first. | Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
| Mean Change From Screening in C-Telopeptide of Type I Collagen (CTX) and Procollagen Type I N-Terminal Propeptide (P1NP) at End of Treatment Cycle 3 | Potential effects on bone was monitored by biomarkers of bone resorption and formation. Bone resorption was determined by assessing CTX level and bone formation was determined by assessing P1NP level. Screening (Visit 1) was defined as the last measurement before study drug administration. | Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
| Mean Change From Screening in Bone-Specific Alkaline Phosphatase (BSAP) and Osteocalcin at End of Treatment Cycle 3 | Potential effects on bone was monitored by biomarkers of bone resorption and formation. Bone formation was determined by assessing BSAP and osteocalcin level. Screening (Visit 1) was defined as the last measurement before study drug administration. | Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
| Mean Change From Screening in N-Telopeptide of Type I Collagen (NTX) at End of Treatment Cycle 3 | Potential effects on bone was monitored by biomarkers of bone resorption and formation. Bone resorption was determined by assessing NTX level. Screening (Visit 1) was defined as the last measurement before study drug administration. nmol BCE/L= nanomoles of bone collagen equivalents per liter. | Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
| Mean Change From Screening in Tartrate-Resistant Acid Phosphatase 5b (TRAP5b) at End of Treatment Cycle 3 | Potential effects on bone was monitored by biomarkers of bone resorption and formation. Bone resorption was determined by assessing TRAP5b level. Screening (Visit 1) was defined as the last measurement before study drug administration. | Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Blood samples were collected to determine the clinical laboratory abnormalities. The laboratory assessments included chemistry, hematology and urinalysis. | From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days |
| Mean Change From Baseline Cycle in Sum of Days on Period at Treatment Cycles 1, 2 and 3 | Participants recorded the presence of bleeding or spotting daily in the eDiary. The daily questions to assess bleeding pattern in the eDiary were "1a: During the past 24 hours, did you have any vaginal bleeding or spotting? If the response is "Yes", then the next question is, "1b: During the past 24 hours, have you been on your period?". Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first. | Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Parameters Abnormalities | Triplicate standard 12-lead ECGs was obtained after the participant was in supine position for at least 5 minutes. The ECG measurements was summarized by taking the average of the available assessments. Only clinically significant ECG abnormalities are reported. | From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days |
| Mean Change From Screening in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3 | Blood samples were collected to determine the serum level of LH and FSH. The LH surge was determined with urine LH kit at home. Screening (Visit 1) was defined as the last measurement before study drug administration. | Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
| Mean Change From Screening in Estrone (E1) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3 | Blood samples were collected to determine the serum level of E1. The LH surge was determined with urine LH kit at home. Screening (Visit 1) was defined as the last measurement before study drug administration. | Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
| Mean Change From Screening in Progesterone, Testosterone and Dehydroepiandrosterone (DHEA) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3 | Blood samples were collected to determine the serum level of progesterone, testosterone and DHEA. The LH surge was determined with urine LH kit at home. Screening (Visit 1) was defined as the last measurement before study drug administration. | Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
| Mean Change From Screening in Free Testosterone and Estradiol (E2) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3 | Blood samples were collected to determine the serum level of free testosterone and E2. The LH surge was determined with urine LH kit at home. Screening (Visit 1) was defined as the last measurement before study drug administration. | Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
| Mean Change From Screening in Dehydroepiandrosterone Sulfate (DHEAS) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3 | Blood samples were collected to determine the serum level of DHEAS. The LH surge was determined with urine LH kit at home. Screening (Visit 1) was defined as the last measurement before study drug administration. | Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
| Plasma Concentrations of OG-6219 and FOR-1011 | Blood samples were collected to determine plasma concentration of OG-6219 and FOR-1011. The plasma concentration of OG-6219 and FOR-1011 was analyzed using an appropriate validated bioanalytical method. | Pre-witness dose and 1.5 hours postdose on start of Treatment Cycle 1 (Day 1), at 7 days after urine LH surge, and end of Treatment Cycle 2; Pre-witness dose on end of Treatment Cycle 3 |
| Maximum Concentration (Cmax) of OG-6219 and FOR-1011 | Blood samples were collected to determine Cmax of OG-6219 and FOR-1011. The Cmax of OG-6219 and FOR-1011 was calculated using non-compartmental method. NCA= Noncompartmental analysis. | Pre-witness dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours postdose on start of Treatment Cycle 1 (Day 1) and at 7 days after urine LH surge |
| Time Taken to Reach the Maximum Concentration (Tmax) of OG-6219 and FOR-1011 | Blood samples were collected to determine tmax of OG-6219 and FOR-1011. The tmax of OG-6219 and FOR-1011 was calculated using non-compartmental method. | Pre-witness dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours postdose on start of Treatment Cycle 1 (Day 1) and at 7 days after urine LH surge |
| Area Under the Plasma Concentration-Time Curve During a Dosing Interval (AUCtau) of OG-6219 and FOR-1011 | Blood samples were collected to determine AUCtau of OG-6219 and FOR-1011. The AUCtau of OG-6219 and FOR-1011 was calculated using non-compartmental method. | Pre-witness dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours postdose on start of Treatment Cycle 1 (Day 1) and at 7 days after urine LH surge |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| Olympia Clinical Trials | Los Angeles | California | 90036 | United States |
| Yale Fertility Center | Orange | Connecticut | 06477 | United States |
| Physician Care Clinical Research, LLC | Sarasota | Florida | 34239 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| MediSense Inc | Atlanta | Georgia | 30363 | United States |
| Paramount Research Solutions | College Park | Georgia | 30349 | United States |
| Infinite Clinical Trials | Morrow | Georgia | 30260 | United States |
| The Advanced Gynecologic Surgery Institute | Park Ridge | Illinois | 60068 | United States |
| Ochsner Health Center - Baptist McFarland Medical Plaza | New Orleans | Louisiana | 70115 | United States |
| Omni Fertility and Laser Institute | Shreveport | Louisiana | 71118 | United States |
| John Hopkins University | Baltimore | Maryland | 21205 | United States |
| Bosque Women's Care | Albuquerque | New Mexico | 87109 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267-0502 | United States |
| Centricity Research Dublin | Dublin | Ohio | 43016 | United States |
| Penn State Health Women's Health Clinic | Hershey | Pennsylvania | 17033 | United States |
| Clinical Research of Philadelphia, LLC | Philadelphia | Pennsylvania | 19114 | United States |
| Palmetto Clinical Research | Summerville | South Carolina | 29485 | United States |
| Chattanooga Medical Research, LLC | Chattanooga | Tennessee | 37404 | United States |
| Cedar Health Research, LLC | Euless | Texas | 76040 | United States |
| The Women's Hospital of Texas | Houston | Texas | 77024 | United States |
| Clinical Trial Network LLC | Houston | Texas | 77074 | United States |
| Northeast Clinical Research of San Antonio | San Antonio | Texas | 78233 | United States |
| Wasatch Clinical Research | Salt Lake City | Utah | 84107 | United States |
| Tidewater Clinical Research | Norfolk | Virginia | 23502 | United States |
| Seattle Women's: Health, Research, Gynecology | Seattle | Washington | 98105 | United States |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| AZ Jan Palfijn Gent | Ghent | 9000 | Belgium |
| Universitair Ziekenhuis Ghent | Ghent | 9000 | Belgium |
| Jessa Ziekenhuis Hospital | Hasselt | 3500 | Belgium |
| CHU de Tivoli | La Louvière | 7100 | Belgium |
| Medical Center Repromed EOOD | Pleven | 5800 | Bulgaria |
| UMHAT "Sv. Georgi", EAD | Plovdiv | 4002 | Bulgaria |
| DCC " Ascendent" EAD | Sofia | 1202 | Bulgaria |
| SHATOD - Sofia District, EOOD | Sofia | 1233 | Bulgaria |
| MHAT for women's health - Nadezhda, OOD | Sofia | 1330 | Bulgaria |
| DCC "Alexandrovska", EOOD | Sofia | 1431 | Bulgaria |
| Medical Center Hera EOOD | Sofia | 1510 | Bulgaria |
| Group practice for specialized medical care in the field of obstetrics and gynecology - Gin Art OOD | Sofia | 1606 | Bulgaria |
| MHAT NiaMed OOD | Stara Zagora | 6000 | Bulgaria |
| Acibadem City Clinic MC Varna EOOD | Varna | 9002 | Bulgaria |
| Fakultni nemocnice Brno | Brno | 602 00 | Czechia |
| Fertimed s.r.o. | Olomouc | 77900 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 100 34 | Czechia |
| Femina Sana s.r.o. | Prague | 130 00 | Czechia |
| Ustav pro peci o matku a dite | Prague | 147 10 | Czechia |
| Hopital Saint Joseph Paris | Paris | Paris | 75674 | France |
| Hôpital Cochin | Paris | 75014 | France |
| Hopital Tenon | Paris | 75020 | France |
| Hospital of Hautepierre | Strasbourg | 67200 | France |
| Universitaetsklinikum Duesseldorf AoeR | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Charité - Campus Benjamin Franklin | Berlin | 13353 | Germany |
| Universitätsklinikum des Saarlandes | Homburg | D-66421 | Germany |
| Clinexpert Kft. | Budapest | 1033 | Hungary |
| Semmelweis Egyetem | Budapest | 1082 | Hungary |
| Szent Anna Maganrendelo | Debrecen | 4024 | Hungary |
| Somogy Varmegyei Kaposi Mor Oktato Korhaz | Kaposvár | 7400 | Hungary |
| Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz | Nyíregyháza | 4400 | Hungary |
| Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico | Seriate | Milano | 20122 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Roma | 168 | Italy |
| Università di Cagliari-Presidio Policlinico Monserrato | Monserrato | 09042 | Italy |
| University of Siena Policlinico | Siena | 53100 | Italy |
| Centro Ricerche Cliniche di Verona s.r.l. | Verona | 37134 | Italy |
| Latvian Maritime Medical Centre | Riga | LV-1005 | Latvia |
| Vitols & Vitols, Ltd. | Riga | LV-1006 | Latvia |
| Dr. Vasaraudze's Private Clinic | Riga | LV-1011 | Latvia |
| Przychodnia Wielospecjalistyczna Sk-Medica Spółka Z O.O. | Wroclaw | Dolnoslask | 54-034 | Poland |
| Specjalistyczna Poradnia Ginekologiczna Janusz Tomaszewski Spółka Komandytowa | Bialystok | 15-224 | Poland |
| Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian | Bialystok | 15-267 | Poland |
| Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian | Katowice | 40-081 | Poland |
| Clinical Medical Research Sp. z o.o. | Katowice | 40-156 | Poland |
| NZOZ Medem | Katowice | 40-301 | Poland |
| Centra Medyczne Medyceusz | Lodz | 91-053 | Poland |
| Specjalistyczny Gabinet Ginekologiczno-Położniczy | Lublin | 20-064 | Poland |
| Centrum Medyczne Chodzki HLK | Lublin | 20-093 | Poland |
| KO-MED Centra Kliniczne Lublin II | Lublin | 20-362 | Poland |
| ETYKA Osrodek Badan Klinicznych | Olsztyn | 10-117 | Poland |
| Etg Siedlce | Siedlce | 08-110 | Poland |
| Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian | Szczecin | 70-225 | Poland |
| MICS Centrum Medyczne Torun | Torun | 87-100 | Poland |
| Specjalistyczna Praktyka Lekar | Warsaw | 00-144 | Poland |
| PRATIA S.A. MTZ Clinical Research Powered by Pratia | Warsaw | 02-172 | Poland |
| WIM Panstwowy Instytut Badawczy Centralny Szpital Kliniczny MON | Warsaw | 04-141 | Poland |
| Karolinska University Hospital | Stockholm | 17176 | Sweden |
| Danderyd Sjukhus | Stockholm | 182 88 | Sweden |
Participants received OG-6219 50 milligrams (mg) (1x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration.
| FG002 | OG-6219 100 mg | Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| FG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| COMPLETED |
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| NOT COMPLETED |
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Full analysis set included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matching with OG-6219 orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| BG001 | OG-6219 50 mg | Participants received OG-6219 50 mg (1x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| BG002 | OG-6219 100 mg | Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| BG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Race data was not collected for participants enrolled in France. | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Ethnicity data was not collected for participants enrolled in France. | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Overall Pelvic Pain (OPP) Score | Participants completed electronic diary (eDiary) items for severity of their pain over the last 24 hours on 11-point numeric rating scale (NRS) for dysmenorrhea or non-menstrual pelvic pain (NMPP), and dyspareunia. Each item of NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. The OPP score was derived by pain score for dysmenorrhea and NMPP items, and score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. Baseline OPP score= Average daily OPP during baseline cycle. | Modified full analysis set included all randomized participants who received at least 1 dose of study drug and who completed at least 1 subsequent diary entry for dysmenorrhea or NMPP. | Mean | Standard Deviation | score on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Change From Baseline Cycle in Mean Overall Pelvic Pain Score at Treatment Cycle 3 | Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dysmenorrhea or NMPP, and dyspareunia. Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. The mean OPP score was derived by the pain score for the dysmenorrhea and NMPP items, and score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. Baseline cycle OPP score was defined as the average daily OPP during baseline cycle. | Modified full analysis set included all randomized participants who received at least 1 dose of study drug and who completed at least 1 subsequent diary entry for dysmenorrhea or NMPP. | Posted | Mean | Standard Deviation | score on a scale | Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
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| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered an investigational product and which does not necessarily have a causal relationship with this treatment. An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. TEAEs were defined as events that first occur or worsen (increase in severity) after the first dose of study drug, during the treatment period, and up to 14 days (inclusive) after the last dose of study drug administration. Percentages are rounded off to the hundredth decimal place. | Safety analysis set included all randomized participants who received at least 1 dose of randomized study drug. | Posted | Number | percentage of participants | From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days |
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| Primary | Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation | An AE was defined as any untoward medical occurrence in a clinical study participant administered an investigational product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as events that first occur or worsen (increase in severity) after the first dose of study drug, during the treatment period, and up to 14 days (inclusive) after the last dose of study drug administration. The TEAEs leading to permanent discontinuation of study drug was identified by using the 'Action taken with study treatment' variable equal to 'Drug withdrawal' from the AE page of the electronic case report form. Percentages are rounded off to the hundredth decimal place. | Safety analysis set included all randomized participants who received at least 1 dose of randomized study drug. | Posted | Number | percentage of participants | From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days |
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| Secondary | Change From Baseline Cycle in Mean Dysmenorrhea Score at Treatment Cycle 3 | Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dysmenorrhea. Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. The mean dysmenorrhea score was calculated for each cycle as the total of daily dysmenorrhea scores reported during the cycle divided by the number of days during the cycle when a dysmenorrhea score was reported. Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first. | Modified full analysis set included all randomized participants who received at least 1 dose of study drug and who completed at least 1 subsequent diary entry for dysmenorrhea or NMPP. | Posted | Mean | Standard Deviation | score on a scale | Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
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| Secondary | Change From Baseline Cycle in Mean Non-Menstrual Pelvic Pain Score at Treatment Cycle 3 | Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dysmenorrhea. Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. The mean NMPP score was calculated for each cycle as the total of daily NMPP scores reported during the cycle divided by the number of days during the cycle when a NMPP score was reported. Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first. | Modified full analysis set included all randomized participants who received at least 1 dose of study drug and who completed at least 1 subsequent diary entry for dysmenorrhea or NMPP. | Posted | Mean | Standard Deviation | score on a scale | Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
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| Secondary | Change From Baseline Cycle in Mean Dyspareunia Score at Treatment Cycle 3 | Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dyspareunia. Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. The mean dyspareunia score was calculated for each cycle as the total of dyspareunia scores reported during each cycle divided by the number of days when participants engaged in any sexual activity that involved full vaginal penetration during each cycle (that is, the number of days during the baseline cycle when a dyspareunia score was reported). Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first. | Modified full analysis set included all randomized participants who received at least 1 dose of study drug and who completed at least 1 subsequent diary entry for dysmenorrhea or NMPP. | Posted | Mean | Standard Deviation | score on a scale | Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
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| Secondary | Change From Baseline Cycle in Mean Number of Rescue Medication Tablets Used for Endometriosis-Related Pain at Treatment Cycles 1, 2 and 3 | Participants were asked daily whether they used the rescue medication in the past 24 hours to treat their ERP. If yes, the number of tablets was documented. The mean number of tablets of rescue medication for ERP was calculated for each cycle as the total number of tablets of rescue medication for ERP reported during the cycle, divided by the number of days during the cycle when a value was reported. Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first. | Modified full analysis set included all randomized participants who received at least 1 dose of study drug and who completed at least 1 subsequent diary entry for dysmenorrhea or NMPP. During the study, participants missed few scheduled site visits for sample collection, and only participants with data collected at specific timepoints are reported. | Posted | Mean | Standard Deviation | mean number of tablets | Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
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| Secondary | Change From Baseline Cycle in Percentage of Days With Participants Used Rescue Medication for Endometriosis-Related Pain at Treatment Cycles 1, 2 and 3 | Participants were asked daily whether they used the rescue medication in the past 24 hours to treat their ERP. If yes, the number of tablets was documented. The percentage of days participant had used rescue medication for ERP was calculated for each cycle as the total number of days participant had used any rescue medication for ERP, divided by the number of days during the cycle when a value was reported. Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first. | Modified full analysis set included all randomized participants who received at least 1 dose of study drug and who completed at least 1 subsequent diary entry for dysmenorrhea or NMPP. During the study, participants missed few scheduled site visits for sample collection, and only participants with data collected at specific timepoints are reported. | Posted | Mean | Standard Deviation | percentage of days | Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
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| Secondary | Change From Start of Treatment Cycle 1 in Participants With Patient Global Impression of Severity (PGI-S) to Start of Treatment Cycle 2, End of Treatment Cycles 2 and 3 | The PGI-S was a single item measuring the overall severity of pelvic pain over the past 7 days on a 4-point Likert-type scale (0=None, 1=Mild, 2=Moderate, 3=Severe), score ranged from 0 (none) and 3 (severe), where lower score indicated a better outcome. Treatment Cycle 1 was the period between the first day of menses associated with treatment start (Visit 4) to the day prior to the first day of next menses, regardless of number of days. | Modified full analysis set included all randomized participants who received at least 1 dose of study drug and who completed at least 1 subsequent diary entry for dysmenorrhea or NMPP. During the study, participants missed few scheduled site visits for sample collection, and only participants with data collected at specific timepoints are reported. | Posted | Count of Participants | Participants | No | Start of Treatment Cycle 1 (Day 1) and start of Treatment Cycle 2 (Day 33), end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
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| Secondary | Percentage of Participants With Any Improvement on the Patient Global Impression of Change (PGI-C) at Start of Treatment Cycle 2 and End of Treatment Cycles 2 and 3 | The PGI-C was a single item measuring the change in pelvic pain since the start of the study drug on a 5-point scale (0=much better, 1=a little better, 2=no change, 3=a little worse, 4=much worse), score ranged from 0 (much better) and 4 (much worse), where lower score indicated a better outcome. Participants with any improvement on the PGI-C were defined as a PGI-C score of 0 or 1 (0=much better and 1=a little better). Treatment Cycle 2 was the period between the first day of menses associated with start of treatment Cycle 2 to the day prior to the first day of next menses, regardless of number of days. | Modified full analysis set included all randomized participants who received at least 1 dose of study drug and who completed at least 1 subsequent diary entry for dysmenorrhea or NMPP. | Posted | Number | percentage of participants | Start of Treatment Cycle 2 (Day 33), end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
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| Secondary | Change From Baseline Cycle in Endometriosis Health Profile-30 (EHP-30) Domains Score at Treatment Cycle 3 | The EHP-30 was a validated disease specific patient-reported outcome instrument measuring the health-related quality of life of women with endometriosis on a 5-point Likert-type scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=always). The EHP-30 consisted of 30 items with following domains: pain (11 items), score ranged from 0 (never) to 44 (always); controls and powerlessness (6 items), score ranged from 0 (never) to 24 (always); emotional well-being (6 items), score ranged from 0 (never) to 24 (always); social support (4 items), score ranged from 0 (never) to 16 (always); and self-image (3 items), score ranged from 0 (never) to 12 (always). Each domain lower score indicated a better outcome. Total EHP-30 score ranged from 0 (never) and 120 (always), where lower score indicated a better outcome. Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first. | Modified full analysis set included all randomized participants who received at least 1 dose of study drug and who completed at least 1 subsequent diary entry for dysmenorrhea or NMPP. | Posted | Mean | Standard Deviation | score on a scale | Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
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| Secondary | Mean Change From Screening in C-Telopeptide of Type I Collagen (CTX) and Procollagen Type I N-Terminal Propeptide (P1NP) at End of Treatment Cycle 3 | Potential effects on bone was monitored by biomarkers of bone resorption and formation. Bone resorption was determined by assessing CTX level and bone formation was determined by assessing P1NP level. Screening (Visit 1) was defined as the last measurement before study drug administration. | Safety analysis set included all randomized participants who received at least 1 dose of randomized study drug. During the study, participants missed few scheduled site visits for sample collection, and only participants with data collected at specific timepoints are reported. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
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| Secondary | Mean Change From Screening in Bone-Specific Alkaline Phosphatase (BSAP) and Osteocalcin at End of Treatment Cycle 3 | Potential effects on bone was monitored by biomarkers of bone resorption and formation. Bone formation was determined by assessing BSAP and osteocalcin level. Screening (Visit 1) was defined as the last measurement before study drug administration. | Safety analysis set included all randomized participants who received at least 1 dose of randomized study drug. During the study, participants missed few scheduled site visits for sample collection, and only participants with data collected at specific timepoints are reported. | Posted | Mean | Standard Deviation | microgram per liter | Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
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| Secondary | Mean Change From Screening in N-Telopeptide of Type I Collagen (NTX) at End of Treatment Cycle 3 | Potential effects on bone was monitored by biomarkers of bone resorption and formation. Bone resorption was determined by assessing NTX level. Screening (Visit 1) was defined as the last measurement before study drug administration. nmol BCE/L= nanomoles of bone collagen equivalents per liter. | Safety analysis set included all randomized participants who received at least 1 dose of randomized study drug. | Posted | Mean | Standard Deviation | nmol BCE/L | Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
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| Secondary | Mean Change From Screening in Tartrate-Resistant Acid Phosphatase 5b (TRAP5b) at End of Treatment Cycle 3 | Potential effects on bone was monitored by biomarkers of bone resorption and formation. Bone resorption was determined by assessing TRAP5b level. Screening (Visit 1) was defined as the last measurement before study drug administration. | Safety analysis set included all randomized participants who received at least 1 dose of randomized study drug. | Posted | Mean | Standard Deviation | units per liter | Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
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| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities | Blood samples were collected to determine the clinical laboratory abnormalities. The laboratory assessments included chemistry, hematology and urinalysis. | Safety analysis set included all randomized participants who received at least 1 dose of randomized study drug. | Posted | Count of Participants | Participants | No | From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days |
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| Secondary | Mean Change From Baseline Cycle in Sum of Days on Period at Treatment Cycles 1, 2 and 3 | Participants recorded the presence of bleeding or spotting daily in the eDiary. The daily questions to assess bleeding pattern in the eDiary were "1a: During the past 24 hours, did you have any vaginal bleeding or spotting? If the response is "Yes", then the next question is, "1b: During the past 24 hours, have you been on your period?". Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first. | Safety analysis set included all randomized participants who received at least 1 dose of randomized study drug. During the study, participants missed few scheduled site visits for sample collection, and only participants with data collected at specific timepoints are reported. | Posted | Mean | Standard Deviation | days | Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
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| Secondary | Number of Participants With Clinically Significant Electrocardiogram (ECG) Parameters Abnormalities | Triplicate standard 12-lead ECGs was obtained after the participant was in supine position for at least 5 minutes. The ECG measurements was summarized by taking the average of the available assessments. Only clinically significant ECG abnormalities are reported. | Safety analysis set included all randomized participants who received at least 1 dose of randomized study drug. | Posted | Count of Participants | Participants | No | From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days |
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| Secondary | Mean Change From Screening in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3 | Blood samples were collected to determine the serum level of LH and FSH. The LH surge was determined with urine LH kit at home. Screening (Visit 1) was defined as the last measurement before study drug administration. | The Pharmacodynamic (PD) analysis set included all participants who took at least 1 dose of OG-6219 or Placebo and had at least 1 quantifiable PD endpoint without protocol deviations or events affecting the PD results. During the study, participants missed few scheduled site visits for sample collection, and only participants with data collected at specific timepoints are reported. | Posted | Mean | Standard Deviation | international units per liter | Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
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| Secondary | Mean Change From Screening in Estrone (E1) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3 | Blood samples were collected to determine the serum level of E1. The LH surge was determined with urine LH kit at home. Screening (Visit 1) was defined as the last measurement before study drug administration. | The PD analysis set included all participants who took at least 1 dose of OG-6219 or Placebo and had at least 1 quantifiable PD endpoint without protocol deviations or events affecting the PD results. During the study, participants missed few scheduled site visits for sample collection, and only participants with data collected at specific timepoints are reported. | Posted | Mean | Standard Deviation | picogram per mL | Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
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| Secondary | Mean Change From Screening in Progesterone, Testosterone and Dehydroepiandrosterone (DHEA) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3 | Blood samples were collected to determine the serum level of progesterone, testosterone and DHEA. The LH surge was determined with urine LH kit at home. Screening (Visit 1) was defined as the last measurement before study drug administration. | The PD analysis set included all participants who took at least 1 dose of OG-6219 or Placebo and had at least 1 quantifiable PD endpoint without protocol deviations or events affecting the PD results. During the study, participants missed few scheduled site visits for sample collection, and only participants with data collected at specific timepoints are reported. | Posted | Mean | Standard Deviation | nanomoles per liter | Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
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| Secondary | Mean Change From Screening in Free Testosterone and Estradiol (E2) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3 | Blood samples were collected to determine the serum level of free testosterone and E2. The LH surge was determined with urine LH kit at home. Screening (Visit 1) was defined as the last measurement before study drug administration. | The PD analysis set included all participants who took at least 1 dose of OG-6219 or Placebo and had at least 1 quantifiable PD endpoint without protocol deviations or events affecting the PD results. During the study, participants missed few scheduled site visits for sample collection, and only participants with data collected at specific timepoints are reported. | Posted | Mean | Standard Deviation | picomoles per liter | Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
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| Secondary | Mean Change From Screening in Dehydroepiandrosterone Sulfate (DHEAS) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3 | Blood samples were collected to determine the serum level of DHEAS. The LH surge was determined with urine LH kit at home. Screening (Visit 1) was defined as the last measurement before study drug administration. | The PD analysis set included all participants who took at least 1 dose of OG-6219 or Placebo and had at least 1 quantifiable PD endpoint without protocol deviations or events affecting the PD results. During the study, participants missed few scheduled site visits for sample collection, and only participants with data collected at specific timepoints are reported. | Posted | Mean | Standard Deviation | micromoles per liter | Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days). |
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| Secondary | Plasma Concentrations of OG-6219 and FOR-1011 | Blood samples were collected to determine plasma concentration of OG-6219 and FOR-1011. The plasma concentration of OG-6219 and FOR-1011 was analyzed using an appropriate validated bioanalytical method. | The Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of OG-6219 and had at least 1 quantifiable OG-6219 or FOR-1011 concentration, which was not impacted by protocol violations or events with potential to affect the PK. During the study, participants missed few scheduled site visits for sample collection, and only participants with data collected at specific timepoints are reported. | Posted | Mean | Standard Deviation | ng/mL | Pre-witness dose and 1.5 hours postdose on start of Treatment Cycle 1 (Day 1), at 7 days after urine LH surge, and end of Treatment Cycle 2; Pre-witness dose on end of Treatment Cycle 3 |
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| Secondary | Maximum Concentration (Cmax) of OG-6219 and FOR-1011 | Blood samples were collected to determine Cmax of OG-6219 and FOR-1011. The Cmax of OG-6219 and FOR-1011 was calculated using non-compartmental method. NCA= Noncompartmental analysis. | The PK analysis set for NCA included all participants in PK analysis set who chose intensive PK sampling in Day 1 and 7 days after urine LH surge and have sufficient samples to determine at least 1 PK parameter for OG-6219 or FOR-1011. Sample size for the optional intensive PK sampling was small and only participants with data collected at specific timepoints are reported. For the OG 6219 150 mg reporting group, no participants completed intensive PK sampling. Thus, no data was collected. | Posted | Mean | Standard Deviation | ng/mL | Pre-witness dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours postdose on start of Treatment Cycle 1 (Day 1) and at 7 days after urine LH surge |
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| Secondary | Time Taken to Reach the Maximum Concentration (Tmax) of OG-6219 and FOR-1011 | Blood samples were collected to determine tmax of OG-6219 and FOR-1011. The tmax of OG-6219 and FOR-1011 was calculated using non-compartmental method. | The PK analysis set for NCA included all participants in PK analysis set who chose intensive PK sampling in Day 1 and 7 days after urine LH surge and have sufficient samples to determine at least 1 PK parameter for OG-6219 or FOR-1011. Sample size for the optional intensive PK sampling was small and only participants with data collected at specific timepoints are reported. For the OG 6219 150 mg reporting group, no participants completed intensive PK sampling. Thus, no data was collected. | Posted | Median | Full Range | hour | Pre-witness dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours postdose on start of Treatment Cycle 1 (Day 1) and at 7 days after urine LH surge |
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| Secondary | Area Under the Plasma Concentration-Time Curve During a Dosing Interval (AUCtau) of OG-6219 and FOR-1011 | Blood samples were collected to determine AUCtau of OG-6219 and FOR-1011. The AUCtau of OG-6219 and FOR-1011 was calculated using non-compartmental method. | The PK analysis set for NCA included all participants in PK analysis set who chose intensive PK sampling in Day 1 and 7 days after urine LH surge and have sufficient samples to determine at least 1 PK parameter for OG-6219 or FOR-1011. Sample size for the optional intensive PK sampling was small and only participants with data collected at specific timepoints are reported. For the OG 6219 150 mg reporting group, no participants completed intensive PK sampling. Thus, no data was collected. | Posted | Mean | Standard Deviation | hour*ng/mL | Pre-witness dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours postdose on start of Treatment Cycle 1 (Day 1) and at 7 days after urine LH surge |
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TEAEs are reported from the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days.
Safety analysis set included all randomized participants who received at least 1 dose of randomized study drug.
TEAEs was defined as events that first occur or worsen (increase in severity) after the first dose of study drug, during the treatment period, and up to 14 days (inclusive) after the last dose of study drug administration. Only TEAEs and TESAEs in double-blind treatment period were collected and reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo matching with OG-6219 orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. | 0 | 88 | 0 | 88 | 45 | 88 |
| EG001 | OG-6219 50 mg | Participants received OG-6219 50 mg (1x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. | 0 | 88 | 1 | 88 | 46 | 88 |
| EG002 | OG-6219 100 mg | Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. | 0 | 88 | 0 | 88 | 45 | 88 |
| EG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. | 0 | 89 | 0 | 89 | 49 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
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| Methaemoglobinaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
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| Atrioventricular block first degree | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
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| Lown-Ganong-Levine syndrome | Congenital, familial and genetic disorders | MedDRA 28.0 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA 28.0 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Terminal ileitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Allergy to animal | Immune system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Beta haemolytic streptococcal infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Fungal foot infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Tonsillitis bacterial | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Bilirubin conjugated increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood bilirubin | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood bilirubin unconjugated increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood methaemoglobin present | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood testosterone free increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood testosterone increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Sacral pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Sleep deficit | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Affect lability | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Breast tenderness | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Adnexa uteri cyst | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Breast cyst | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haemorrhagic ovarian cyst | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Polymenorrhoea | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vulvovaginal burning sensation | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Spinal operation | Surgical and medical procedures | MedDRA 28.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Lead, Late-Stage Clinical Development | Organon LLC, a subsidiary of Organon and Co. | 551-430-6000 | pdrl@organon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2025 | Feb 5, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided
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| Bulgaria |
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| Czechia |
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| France |
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| Germany |
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| Hungary |
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| Italy |
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| Latvia |
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| Poland |
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| Sweden |
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| United States |
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Participants received OG-6219 50 mg (1x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration.
| OG002 | OG-6219 100 mg | Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| OG002 | OG-6219 100 mg | Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| OG002 | OG-6219 100 mg | Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| OG002 | OG-6219 100 mg | Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
Participants received OG-6219 50 mg (1x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration.
| OG002 | OG-6219 100 mg | Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
Participants received OG-6219 50 mg (1x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG002 | OG-6219 100 mg | Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
Participants received OG-6219 50 mg (1x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG002 | OG-6219 100 mg | Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| OG002 | OG-6219 100 mg | Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| OG002 | OG-6219 100 mg | Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| OG001 | OG-6219 50 mg | Participants received OG-6219 50 mg (1x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG002 | OG-6219 100 mg | Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| OG-6219 100 mg |
Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration.
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| OG003 |
| OG-6219 150 mg |
Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| OG002 | OG-6219 100 mg | Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| OG002 | OG-6219 100 mg | Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| OG-6219 100 mg |
Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| OG002 | OG-6219 100 mg | Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| OG002 |
| OG-6219 100 mg |
Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| OG002 |
| OG-6219 100 mg |
Participants received OG-6219 100 mg (2x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
| OG003 | OG-6219 150 mg | Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| OG-6219 150 mg |
Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| OG-6219 150 mg |
Participants received OG-6219 150 mg (3x50 mg tablet) orally BID from Cycle 1 to Cycle 3. Each cycle referred to 1 menstrual cycle of around 21 to 32-day duration. |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
| None |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
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|
|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|