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

NCT01116440 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-11-23

Study results available
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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

Conditions

  • Pelvic Pain Associated With Refractory Endometriosis

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.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Mereo BioPharma

    lead INDUSTRY

Principal Investigators

  • Jacqueline Parkin, PhD FRCP · Mereo BioPharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-15
Primary Completion
2011-07-31
Completion
2012-03-21

Countries

  • United States
  • Puerto Rico

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01116440 on ClinicalTrials.gov