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BGS649 Monotherapy in Moderate to Severe Endometriosis Patients

NCT ID: NCT01190475

Last Updated: 2020-10-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-09-30

Brief Summary

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This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis.

Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BGS649 high dose

1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules.

Group Type EXPERIMENTAL

Active treatment with a high dose of BGS649

Intervention Type DRUG

BGS649 low dose

1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules

Group Type EXPERIMENTAL

Active treatment with a low dose of BGS649

Intervention Type DRUG

Placebo to BGS649

1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules

Group Type PLACEBO_COMPARATOR

Placebo treatment to blind study

Intervention Type DRUG

Interventions

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Active treatment with a high dose of BGS649

Intervention Type DRUG

Active treatment with a low dose of BGS649

Intervention Type DRUG

Placebo treatment to blind study

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Premenopausal women with documented moderate to severe endometriosis. Occurrence of three sequential menstrual cycles of 24-35 days duration prior to enrollment.
* Laparoscopically proven diagnosis of moderate to severe endometriosis (diagnosed within the past 10 years before screening).
* Patients not planning to become pregnant within one year after the screening visit and willing to use two effective methods of non-hormonal, barrier birth control for the duration of the study or who are surgically sterile.
* Patients must have a score of at least 4 on the numerical rating scale (NRS) for one of the following three pain measurements: pelvic pain, menstrual pain and dyspareunia

Exclusion Criteria

* Estrogen replacement therapy using either prescription medications or estrogen-containing OTC nutritional/herbal supplements such as soy extracts or topical estrogens.
* Aromatase inhibitor therapy (includes Femara (letrozole), Aromasin (exemestane) or Arimidex (anastrozole) within the past 12 months.
* Oral bisphosphonate therapy (i.e. Fosamax (alendronate)) within the past 6 months or intravenous bisphosphonate (i.e., Reclast, pamidronate) \< 15 months from screening.
* Systemic glucocorticoid therapy within the past 4 weeks.
* Contra-indications to oral contraceptive use.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Mereo BioPharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacqueline Parkin, PhD FRCP

Role: STUDY_DIRECTOR

Mereo BioPharma

Locations

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Novartis Investigative Site

Anaheim, California, United States

Site Status

Countries

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United States

Other Identifiers

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CBGS649A2105

Identifier Type: -

Identifier Source: org_study_id