A Safety & Efficacy Study of BGS649 in Women With Refractory Endometriosis

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2011

Interventions

  • Drug: 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.
  • Drug: 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.

Arms, Groups and Cohorts

  • Experimental: BGS649 co-administered with Levora 28™
  • Placebo Comparator: Placebo co-administered with Levora 28™

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Mean Change From Baseline to 4 Weeks in Numeric Rating Scale Pelvic Pain Scores
    • Time Frame: 4 weeks
    • 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.
  • Percentage of Patients Achieving a Response in Numeric Rating Scale Pelvic Pain Score
    • Time Frame: 12 weeks
    • 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.
  • Mean Change From Baseline in Numeric Rating Scale Pelvic Pain Scores
    • Time Frame: 8 weeks
    • 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.
  • Percentage of Patients Achieving a Response in Their Pelvic Pain Score Measured on the Modified Biberoglu & Behrman Scale
    • Time Frame: 12 weeks
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Exclusion Criteria:

  • 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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 49 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mereo BioPharma
  • Collaborator
    • Novartis
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jacqueline Parkin, PhD FRCP, Study Director, Mereo BioPharma

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