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This trial will assess the efficacy and safety of PGL4001 with concomitant iron administration versus placebo with concomitant iron administration, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (PGL4001 5mg) | Experimental | PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+ |
|
| B (PGL4001 10mg) | Experimental | PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+ |
|
| C (placebo) | Placebo Comparator | PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PGL4001 (ulipristal) and iron | Drug | tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13) | Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss. Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding. A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5. Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used. The week 13 PBAC score was calculated using the last 28 days of treatment. | Week 13 visit |
| Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit) | Percent change in total fibroid volume from screening to end of treatment visit (Week 13 visit) assessed by MRI and read centrally by a radiologist who was unaware of the study-group assignments. The total fibroid volume was the sum of the individual fibroid volumes. | Week 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Elke Bestel | PregLem SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gynekologicko-porodnicka klinika FN Brno | Brno | 625 00 | Czechia | |||
| Mediva |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22296075 | Result | Donnez J, Tatarchuk TF, Bouchard P, Puscasiu L, Zakharenko NF, Ivanova T, Ugocsai G, Mara M, Jilla MP, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL I Study Group. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med. 2012 Feb 2;366(5):409-20. doi: 10.1056/NEJMoa1103182. | |
| 24457604 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | A (PGL4001 5mg) | PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+ |
| FG001 | B (PGL4001 10mg) | PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+ |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| PGL4001 matching placebo and iron | Drug | tablets |
|
|
| PGL4001 (ulipristal) and iron | Drug | Tablets |
|
|
| Prague |
| 110 00 |
| Czechia |
| Gynekologicko-porodnicka klinika 1.LF UK a VFN | Prague | 128 00 | Czechia |
| Gynekologicko-porodnicka klinika UK 2.LF a FN | Prague | 150 06 | Czechia |
| Rethy-Pal Hospital-Clinic Bekescsaba, Department of Obstetrics and Gynecology | Békéscsaba | 5600 | Hungary |
| Saint Stephen Hospital of Budapest,Department of Obstetrics, Gynecology and Gynecological Oncology | Budapest | 1096 | Hungary |
| Fovarosi Bajcsy-Zsilinszky Hospital, Department of Obstetrics and Gynecology | Budapest | 1106 | Hungary |
| Dr. Bugyi Istvan Hospital, Department of Obstetrics and Gynecology | Szentes | 6600 | Hungary |
| Saint George Hospital of Fejer County, Department of Obstetrics and Gynecology | Székesfehérvár | 8000 | Hungary |
| Saint Borbala Hospital of Komarom-Esztergom County, Department of Obstetrics and Gynecology | Tatabánya | 2800 | Hungary |
| Dr. Jilla Hospital | Aurangabad | 431001 | India |
| M. S. Ramaiah Medical College and Memorial Hospital | Bangalore | 560054 | India |
| Divakars Speciality Hospital | Bangalore | 560078 | India |
| Sri Ramachandra Medical College and Research Institute | Chennai | 600116 | India |
| Om Women's Hospital | Nagpur | 440010 | India |
| Nagpur Test Tube Baby Centre | Nagpur | 440022 | India |
| Central Medical Sanador | Bucharest | 011026 | Romania |
| Departamentul de Obstretica Ginecologie si Nou Nascuti | Bucharest | 020395 | Romania |
| Centrul Medical Euromed, departementul de Obstetrica/Ginecologie | Bucharest | 020762 | Romania |
| Sectia Obstretica-Ginecologie Spitalul Clinic Dr. Ioan Cantacuzino | Bucharest | 70266 | Romania |
| Spitalul Clinic de Obstetrica Ginecologie Oradea | Oradea | 410053 | Romania |
| Spitalul Clinic Judetean de urgenta, sectia de obstetrica Ginecologie I | Târgu Mureş | 540136 | Romania |
| Northern State Medical University | Arkhangelsk | 163001 | Russia |
| Kursk State Medical University | Kursk | 305035 | Russia |
| American Medical Clinic | Saint Petersburg | 190000 | Russia |
| Saint-Petersburg City Alexandrovsky Hospital | Saint Petersburg | 193312 | Russia |
| Military Medical Academy n.a.S.M Kirov, chair of Obstetrics and Gynecology | Saint Petersburg | 194044 | Russia |
| Medical Research Institute (MRI) | Saint Petersburg | 196084 | Russia |
| Russian Scientific Research Center of Radiology and Surgical Technologies | Saint Petersburg | 197758 | Russia |
| Scientific Research Institute of Obstetrics and Gynecology n.a. D.O.Ott of RAMS | Saint Petersburg | 199034 | Russia |
| OAO "Medical company IDK" | Samara | 443067 | Russia |
| Donetsk National Medical University, Department of Obstetrics, Gynecology and Perinatology FPE | Donetsk | Ukraine |
| City Clinical Hospital N9 | Kiev | 04112 | Ukraine |
| Institute of Pediatrics, Obstetrics and Gynecology, Department of Endocrine Gynecology | Kiev | Ukraine |
| Kiev Maternity Hospital No.2 | Kiev | Ukraine |
| State Enterprise "Institute of Pediatrics, Obstetrics and Gynecology of AMS of Ukraine | Kyiv | Ukraine |
| Lviv National Medical University named after Danylo Halytskyy | Lviv | 79032 | Ukraine |
| Medical Sanitory Centre VAT "Motor Sich" Gynecology department | Zaporizhzhya | Ukraine |
| Barlow DH, Lumsden MA, Fauser BC, Terrill P, Bestel E. Individualized vaginal bleeding experience of women with uterine fibroids in the PEARL I randomized controlled trial comparing the effects of ulipristal acetate or placebo. Hum Reprod. 2014 Mar;29(3):480-9. doi: 10.1093/humrep/det467. Epub 2014 Jan 23. |
| FG002 | C (Placebo) | PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+ |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A (PGL4001 5mg) | PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+ |
| BG001 | B (PGL4001 10mg) | PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+ |
| BG002 | C (Placebo) | PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+ |
| BG003 | 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 |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Co-primary Endpoint: Percentage of Subjects With Reduction in Uterine Bleeding Defined as a Pictorial Blood-loss Assessment Chart (PBAC) Score <75 at End-of-treatment Visit (Week 13) | Uterine bleeding was assessed with the use of the PBAC, a validated self-reporting method to estimate menstrual blood loss. Patients recorded daily the number of tampons and towels used and the degree to which individual items were soiled with blood (plus small or large clots). Monthly scores range from 0 (amenorrhea) to more than 500, with higher numbers indicating more bleeding. A slightly stained tampon/towel scores 1, a partially stained tampon/towel scores 5, a completely saturated tampon scores 10 and a completely saturated towel scores 20. Small clots/flooding (2cm) score 1. Large clots/flooding (3cm) score 5. Menorrhagia is defined as a PBAC > 100 during one menstrual period which approximates to a blood loss of > 80 mL. A PBAC of 400 corresponds to a blood loss of around 300 mL or approximately 80 tampons/towels used. The week 13 PBAC score was calculated using the last 28 days of treatment. | Intent-to-treat | Posted | Number | percentage of patients | Week 13 visit |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Co-primary Endpoint: Percent Change in Total Myoma Volume Assessed by Magnetic Resonance Imaging (MRI) From Screening to End of Treatment Visit (Week 13 Visit) | Percent change in total fibroid volume from screening to end of treatment visit (Week 13 visit) assessed by MRI and read centrally by a radiologist who was unaware of the study-group assignments. The total fibroid volume was the sum of the individual fibroid volumes. | Intent-to-treat | Posted | Median | Full Range | percentage of change | Week 13 |
|
|
3 years 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A (PGL4001 5mg) | PGL4001 5 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+ | 2 | 95 | 47 | 95 | ||
| EG001 | B (PGL4001 10mg) | PGL4001 10 mg (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+ | 1 | 98 | 52 | 98 | ||
| EG002 | C (Placebo) | PGL4001 matching placebo (oral tablets) with concomitant oral administration of 1 tablet containing 80 mg Fe2+ | 2 | 48 | 22 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian hemorrhage | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Uterine hemorrhage | Reproductive system and breast disorders | Systematic Assessment |
| ||
| New uterine leiomyoma | Reproductive system and breast disorders | Systematic Assessment |
| ||
| breast cancer | Reproductive system and breast disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Breat pain / tenderness / disconfort | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Dysmenorrhea | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
| ||
| Hypercholesterolemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Reproductive system and breast disorders | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Nervous system disorders | Nervous system disorders | Systematic Assessment |
| ||
| Infections and infestations | Infections and infestations | Systematic Assessment |
| ||
| Endocrine disorders | Endocrine disorders | Systematic Assessment |
| ||
| General disorders and administration site conditions | General disorders | Systematic Assessment |
| ||
| Diziness | Nervous system disorders | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Elke Bestel | PregLem S.A. | +41 22 884 03 40 | medical@preglem.com |
| ID | Term |
|---|---|
| C094854 | ulipristal |
| D007501 | Iron |
| C555622 | ulipristal acetate |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Hungary |
|
| India |
|
| Romania |
|
| Russian Federation |
|
| Ukraine |
|
| Cochran-Mantel-Haenszel | Adjustment for randomization strata | <0.001 | As comparison involved two doses of PGL4001 vs Placebo, Bonferroni correction used with p values doubled (threshold was 0.05) and confidence intervals adjusted | Difference in proportions | 73.7 | 2-Sided | 95 | 56.2 | 84.0 | Confidence intervals with the use of Newcombe-Wilson score method (uncorrected) | No | Superiority or Other |
| Participants |
|
|
|