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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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The purpose of this study is to determine efficacy, safety, tolerability and pharmacokinetics of multiple doses of BGS649 with concurrent daily administration of combined oral contraception in patients with refractory endometriosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGS649 co-administered with Levora 28™ | Experimental |
| |
| Placebo co-administered with Levora 28™ | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGS649 | Drug | 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg will be administered at randomization, week 4, and week 8 at the study site. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Baseline to Week 12 in Numeric Rating Scale Pelvic Pain Score | Mean change from baseline to Month 3 (Week 12) in Number Rating Scale pelvic pain score. The Numeric Rating Scale is a scale between 0 and 10 where 0 is no pain and 10 is the worse pain you can imagine. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to 4 Weeks in Numeric Rating Scale Pelvic Pain Scores | Mean change from baseline in Numeric Rating Scale pelvic pain scores to 4 weeks. The Numeric Rating Scale is a scale between 0 and 10 where 0 is no pain and 10 is the worse pain you can imagine. | 4 weeks |
| Percentage of Patients Achieving a Response in Numeric Rating Scale Pelvic Pain Score |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Parkin, PhD FRCP | Mereo BioPharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama Medical Center | Mobile | Alabama | 36617 | United States | ||
| Precision Trials |
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| ID | Title | Description |
|---|---|---|
| FG000 | BGS649 Co-administered With Levora 28™ | BGS649: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg will be administered at randomization, week 4, and week 8 at the study site. |
| FG001 | Placebo Co-administered With Levora 28™ |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
|
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| Placebo | Drug | Placebo matching BGS649 will be provided by Novartis as capsules for oral administration. Three capsules of placebo will be administered at randomization, week 4, and week 8 at the study site. |
|
The proportion (expressed as a percentage) of patients achieving a response in the Numeric Rating Scale pelvic pain score where a response is defined as greater than or equal to 2-point improvement from baseline or a greater than or equal to 30% improvement in the score. The Numeric Rating Scale is a scale between 0 and 10 where 0 is no pain and 10 is the worse pain you can imagine. |
| 12 weeks |
| Mean Change From Baseline in Numeric Rating Scale Pelvic Pain Scores | Mean change from baseline in Numeric Rating Scale pelvic pain scores to 8 weeks. Where the Numeric Rate Scale Pelvic Pain Score is a scale between 0 and 10, where 0 is no pain and is the worse pain you can imagine. | 8 weeks |
| Percentage of Patients Achieving a Response in Their Pelvic Pain Score Measured on the Modified Biberoglu & Behrman Scale | The proportion of patients (expressed as a percentage) achieving a response to their pelvic pain score measure on the Biberoglu and Behrman pelvic pain score where a response is defined as a greater than or equal to 1-point improvement from baseline. B & B scales allow for grading pain with a score between 0 and 4 with higher number being more severe pain. | 12 weeks |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Northeast Arkansas Clinic | Jonesboro | Arkansas | 72401 | United States |
| Center for Fertility and Women's Health | New Britain | Connecticut | 06052 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06504 | United States |
| Zasa Clinical Research | Boynton Beach | Florida | 33437 | United States |
| Women's Medical Research Group, LLC | Clearwater | Florida | 33759 | United States |
| University of Miami School of Medicine & Clinics | Miami | Florida | 33136 | United States |
| West Broward OB/GYN Associates | Plantation | Florida | 33324 | United States |
| Comprehensive Clinical Trials,LLC | West Palm Beach | Florida | 33409 | United States |
| Associated Pharmaceutical Research | Decatur | Georgia | 30034 | United States |
| Legacy Obstetrics & Gynecology | Decatur | Georgia | 30035 | United States |
| Minority Clinical Research Center of Atlanta | Riverdale | Georgia | 30274 | United States |
| Christie Clinic | Champaign | Illinois | 61820 | United States |
| Women's Health Practice Center | Champaign | Illinois | 61820 | United States |
| The Advanced Gynecologic Surgery Institute | Naperville | Illinois | 60540 | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | United States |
| Cypress Medical Research Center, LLC | Wichita | Kansas | 67226 | United States |
| Green Clinic, LLC | Ruston | Louisiana | 71270 | United States |
| NECCR | Fall River | Massachusetts | 02720 | United States |
| Wayne State University | Detroit | Michigan | 48034 | United States |
| Saginaw Valley Medical Research Group, LLC | Saginaw | Michigan | 48604 | United States |
| Montana Medical Research | Missoula | Montana | 59808 | United States |
| Women's Clinic of Lincoln, PC | Lincoln | Nebraska | 68510 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| Women's Health Research Center | Plainsboro | New Jersey | 08536 | United States |
| Southwest Clinical Research | Albuquerque | New Mexico | 87102 | United States |
| New Hanover Medical Research | Wilmington | North Carolina | 28401 | United States |
| Lyndhurst Gynecologic Associates | Winston-Salem | North Carolina | 27103 | United States |
| HWC Women's Research Center | Englewood | Ohio | 45322 | United States |
| Promedica Health System | Toledo | Ohio | 43606 | United States |
| Ilumina Clinical Associates | Hopwood | Pennsylvania | 15445 | United States |
| Medical Research South | Charleston | South Carolina | 29407 | United States |
| Greenville Hospital System | Greenville | South Carolina | 26905 | United States |
| Magnolia OB/GYN Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Practice Research Organization | Dallas | Texas | 75230 | United States |
| Centex Research | Houston | Texas | 77079 | United States |
| Bexar Clinical Trials | Irving | Texas | 75061 | United States |
| R/D Clinical Research, Inc. | Lake Jackson | Texas | 77566 | United States |
| Eastern Va Medical School | Norfolk | Virginia | 23507 | United States |
| VCU Health Systems, MCV | Richmond | Virginia | 23230 | United States |
| Valley Women's Clinic | Renton | Washington | 98055 | United States |
| Henry Rodriguez-Ginorio, MD | San Juan | Pr | 00917 | Puerto Rico |
| Ponce School of Medicine | Ponce | 00716 | Puerto Rico |
Placebo: Placebo matching BGS649 will be provided by Novartis as capsules for oral administration. Three capsules of placebo will be administered at randomization, week 4, and week 8 at the study site. |
| COMPLETED |
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| NOT COMPLETED |
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| Withdrawal |
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| Follow-up |
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Full Analysis Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | BGS649 Co-administered With Levora 28™ | BGS649: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg administered at randomization, week 4, and week 8 at the study site. |
| BG001 | Placebo Co-administered With Levora 28™ | Placebo: Placebo matching BGS649 provided by Novartis as capsules for oral administration. Three capsules of placebo administered at randomization, week 4, and week 8 at the study site. |
| BG002 | 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 |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Mean Change in Baseline to Week 12 in Numeric Rating Scale Pelvic Pain Score | Mean change from baseline to Month 3 (Week 12) in Number Rating Scale pelvic pain score. The Numeric Rating Scale is a scale between 0 and 10 where 0 is no pain and 10 is the worse pain you can imagine. | Full analysis set. All patients randomised excluding those who were randomised inadvertently and did not receive study drug | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline to 4 Weeks in Numeric Rating Scale Pelvic Pain Scores | Mean change from baseline in Numeric Rating Scale pelvic pain scores to 4 weeks. The Numeric Rating Scale is a scale between 0 and 10 where 0 is no pain and 10 is the worse pain you can imagine. | Full Analysis Set. All randomized patients excluding patients randomized inadvertently who did not receive drug (ITT) | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving a Response in Numeric Rating Scale Pelvic Pain Score | The proportion (expressed as a percentage) of patients achieving a response in the Numeric Rating Scale pelvic pain score where a response is defined as greater than or equal to 2-point improvement from baseline or a greater than or equal to 30% improvement in the score. The Numeric Rating Scale is a scale between 0 and 10 where 0 is no pain and 10 is the worse pain you can imagine. | Full Analysis Set. All participants randomized except patients inadvertently randomized who didn't receive study drug (ITT principles) | Posted | Number | percentage of participants | 12 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Numeric Rating Scale Pelvic Pain Scores | Mean change from baseline in Numeric Rating Scale pelvic pain scores to 8 weeks. Where the Numeric Rate Scale Pelvic Pain Score is a scale between 0 and 10, where 0 is no pain and is the worse pain you can imagine. | Full Analysis Set. All randomized patients excluding patients randomized inadvertently who did not receive drug (ITT) | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Patients Achieving a Response in Their Pelvic Pain Score Measured on the Modified Biberoglu & Behrman Scale | The proportion of patients (expressed as a percentage) achieving a response to their pelvic pain score measure on the Biberoglu and Behrman pelvic pain score where a response is defined as a greater than or equal to 1-point improvement from baseline. B & B scales allow for grading pain with a score between 0 and 4 with higher number being more severe pain. | Full Analysis Set. All participants randomized except patients inadvertently randomized who didn't receive study drug (ITT principles) | Posted | Number | percentage of participants | 12 weeks |
|
|
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After unblinding the study, it was found that 1 subject in the placebo arm was dosed with BGS649 and therefore the safety population is 15 and the BGS649 arm is 12.
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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 | BGS649 Co-administered With Levora 28™ | BGS649: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg administered at randomization, week 4, and week 8 at the study site. | 1 | 12 | 10 | 12 | ||
| EG001 | Placebo Co-administered With Levora 28™ | Placebo: Placebo matching BGS649 provided by Novartis as capsules for oral administration. Three capsules of placebo administered at randomization, week 4, and week 8 at the study site. | 2 | 15 | 10 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endometriosis | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Vision blurred | Eye disorders | Systematic Assessment |
| ||
| Abdominal distention | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Irritability | General disorders | Systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Gastroentritis viral | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Muscle strain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Post-traumatic pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Platelet count increased | Investigations | Systematic Assessment |
| ||
| Smear cervix abdominal | Investigations | Systematic Assessment |
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| Weight increased | Investigations | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Amnesia | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Migraine | Nervous system disorders | Systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Psychiatric disorders | Nervous system disorders | Systematic Assessment |
| ||
| Confusional state | Nervous system disorders | Systematic Assessment |
| ||
| Insomnia | Nervous system disorders | Systematic Assessment |
| ||
| Mood swings | Nervous system disorders | Systematic Assessment |
| ||
| Cervical dysplasia | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Dysmenorrhoea | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Endometriosis | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Menorrhagia | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Ovarian cyst ruptured | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Premenstrual syndrome | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Night sweats | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hot flush | Vascular disorders | Systematic Assessment |
|
After unblinding it was found that one of the placebo patients had been given active drug. Therefore the safety populations has 12 patients on active and 15 on placebo. The study was terminated for administrative reasons.
All PIs must seek written permission from the sponsor prior to publication of any trial results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Moore | Mereo BioPharma Group Plc. | +44333023300 | WM@mereobiopharma.com |
| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| D004715 | Endometriosis |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| >=65 years |
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| Male |
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| Black |
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| Other |
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| Participants |
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| Participants |
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