Pelvic Pain Associated With Refractory EndometriosisPhase 2NCT01116440
A Safety & Efficacy Study of BGS649 in Women With Refractory Endometriosis
A Phase 2 study testing BGS649 in people with Pelvic Pain Associated With Refractory Endometriosis, run by Mereo BioPharma at 44 sites in 2 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Pelvic Pain Associated With Refractory Endometriosis
- What is being tested?
- BGS649
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 44 sitesin 2 countries
- Study dates
- 15 Apr 2010to 21 Mar 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Must have surgical diagnosis of endometriosis est. w/in 5 years before screening. Subjects must have self reported moderate to severe pelvic pain at screening to be confirmed during the run-in-phase
- Subjects with moderate to severe pelvic pain who were refractory to surgery (persistent or recurrent pelvic pain within 24 months after any therapeutic surgery) and at least two hormonal therapies from two different classes, including one approved hormonal therapy
Who cannot join
- Subjects who have undergone hysterectomy or bilateral oophorectomy.
- Surgical treatment of endometriosis within 3 months before screening.
- Subjects who are pregnant or who were pregnant within 3 months of visit one.
- Subjects who are nursing or lactating
- Subjects who are tobacco smokers.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
44 sites in 2 countries.
44 sites in 2 countries
United States42 sites
Southwest Clinical Research
Albuquerque, New Mexico, 87102
Zasa Clinical Research
Boynton Beach, Florida, 33437
Cooper University Hospital
Camden, New Jersey, 08103
Christie Clinic
Champaign, Illinois, 61820
Women's Health Practice Center
Champaign, Illinois, 61820
Medical Research South
Charleston, South Carolina, 29407
Women's Medical Research Group, LLC
Clearwater, Florida, 33759
Practice Research Organization
Dallas, Texas, 75230
Associated Pharmaceutical Research
Decatur, Georgia, 30034
Legacy Obstetrics & Gynecology
Decatur, Georgia, 30035
Wayne State University
Detroit, Michigan, 48034
HWC Women's Research Center
Englewood, Ohio, 45322
NECCR
Fall River, Massachusetts, 02720
Greenville Hospital System
Greenville, South Carolina, 26905
Ilumina Clinical Associates
Hopwood, Pennsylvania, 15445
Centex Research
Houston, Texas, 77079
Bexar Clinical Trials
Irving, Texas, 75061
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, 68510
University of Miami School of Medicine & Clinics
Miami, Florida, 33136
Montana Medical Research
Missoula, Montana, 59808
University of South Alabama Medical Center
Mobile, Alabama, 36617
Magnolia OB/GYN Research Center
Myrtle Beach, South Carolina, 29572
The Advanced Gynecologic Surgery Institute
Naperville, Illinois, 60540
Center for Fertility and Women's Health
New Britain, Connecticut, 06052
Yale New Haven Hospital
New Haven, Connecticut, 06504
Eastern Va Medical School
Norfolk, Virginia, 23507
Precision Trials
Phoenix, Arizona, 85032
Women's Health Research Center
Plainsboro, New Jersey, 08536
West Broward OB/GYN Associates
Plantation, Florida, 33324
Valley Women's Clinic
Renton, Washington, 98055
VCU Health Systems, MCV
Richmond, Virginia, 23230
Minority Clinical Research Center of Atlanta
Riverdale, Georgia, 30274
Green Clinic, LLC
Ruston, Louisiana, 71270
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, 48604
Promedica Health System
Toledo, Ohio, 43606
Comprehensive Clinical Trials,LLC
West Palm Beach, Florida, 33409
Heartland Research Associates, LLC
Wichita, Kansas, 67207
Cypress Medical Research Center, LLC
Wichita, Kansas, 67226
New Hanover Medical Research
Wilmington, North Carolina, 28401
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, 27103
Puerto Rico2 sites
Ponce School of Medicine
Ponce, 00716
Henry Rodriguez-Ginorio, MD
San Juan, Pr, 00917
About this study
Official title: A Double Blind, Randomized, Controlled, Multicenter, Efficacy and Safety Study of Oral BGS649 vs. Placebo (Each Co-administered With a Combined Oral Contraceptive) Assessing Pain Response in Patients With Refractory Endometriosis
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
- Being tested
- BGS649, Placebo
- Keywords
- Menstrual pain, Refractory endometriosis, Pelvic pain
- Medical subject headings
- Dysmenorrhea, Endometriosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGS649Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| BGS649 co-administered with Levora 28™ | Experimental | Not described Receives: Drug: BGS649 |
| Placebo co-administered with Levora 28™ | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: 4 weeks
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study start15 Apr 2010
- Primary completionJul 2011
- Study completion21 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pelvic Pain Associated With Refractory EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mereo BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Jacqueline Parkin, PhD FRCP, Study director, Mereo BioPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116440
- Sponsor's protocol ID
- CBGS649A2202
- Status last verified
- Nov 2020
- First submitted
- 3 May 2010
- Last updated
- 23 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Controlled, Multicenter, Efficacy and Safety Study of Oral BGS649 vs. Placebo (Each Co-administered With a Combined Oral Contraceptive) Assessing Pain Response in Patients With Refractory Endometriosis
- ClinicalTrials.gov ID
- NCT01116440
- Acronym / sponsor ID
- CBGS649A2202
- Keywords
- Menstrual pain, Refractory endometriosis, Pelvic pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mereo BioPharmaIndustry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- 15 Apr 2010 (actual)
- Primary completion
- Jul 2011 (actual)
- Study completion
- 21 Mar 2012 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Posted 30 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BGS649 co-administered with Levora 28™ | Experimental | Drug: BGS649 |
| Placebo co-administered with Levora 28™ | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Must have surgical diagnosis of endometriosis est. w/in 5 years before screening. Subjects must have self reported moderate to severe pelvic pain at screening to be confirmed during the run-in-phase
- Subjects with moderate to severe pelvic pain who were refractory to surgery (persistent or recurrent pelvic pain within 24 months after any therapeutic surgery) and at least two hormonal therapies from two different classes, including one approved hormonal therapy
Key exclusion criteria (6 listed)
- Subjects who have undergone hysterectomy or bilateral oophorectomy.
- Surgical treatment of endometriosis within 3 months before screening.
- Subjects who are pregnant or who were pregnant within 3 months of visit one.
- Subjects who are nursing or lactating
- Subjects who are tobacco smokers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGS6490.1 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. | Drug | BGS649 co-administered with Levora 28™ |
| PlaceboPlacebo 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. | Drug | Placebo co-administered with Levora 28™ |
Primary outcome
Mean Change in Baseline to Week 12 in Numeric Rating Scale Pelvic Pain Score
Time frame: 12 weeks
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.
4 secondary outcomes
Mean Change From Baseline to 4 Weeks in Numeric Rating Scale Pelvic Pain Scores
Time frame: 4 weeks
Percentage of Patients Achieving a Response in Numeric Rating Scale Pelvic Pain Score
Time frame: 12 weeks
Mean Change From Baseline in Numeric Rating Scale Pelvic Pain Scores
Time frame: 8 weeks
Percentage of Patients Achieving a Response in Their Pelvic Pain Score Measured on the Modified Biberoglu & Behrman Scale
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pelvic Pain Associated With Refractory Endometriosis
Recruiting
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Pelvic Pain Associated With Endometriosis or Adenomyosis, Pelvic Pain Associated With Refractory Endometriosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline Parkin, PhD FRCP study director
Mereo BioPharma
44 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BGS649 in people with Pelvic Pain Associated With Refractory Endometriosis, run by Mereo BioPharma at 44 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Baseline to Week 12 in Numeric Rating Scale Pelvic Pain Score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.