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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
27
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.
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.
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.
Time frame: 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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University of South Alabama Medical Center
Mobile, Alabama, United States
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Jonesboro, Arkansas, United States
Center for Fertility and Women's Health
New Britain, Connecticut, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Zasa Clinical Research
Boynton Beach, Florida, United States
Women's Medical Research Group, LLC
Clearwater, Florida, United States
University of Miami School of Medicine & Clinics
Miami, Florida, United States
West Broward OB/GYN Associates
Plantation, Florida, United States
Comprehensive Clinical Trials,LLC
West Palm Beach, Florida, United States
...and 34 more locations
Time frame: 12 weeks