BGS649 Monotherapy in Moderate to Severe Endometriosis Patients

Phase 2

Completed

Interventions: Drug: Placebo treatment to blind study
Drug: Active treatment with a high dose of BGS649
Drug: Active treatment with a low dose of BGS649

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

Recruitment & Eligibility

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.

Other protocol-defined inclusion/exclusion criteria may apply

Arm && Interventions

Group	Intervention	Description
Placebo to BGS649	Placebo treatment to blind study	1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules
BGS649 high dose	Active treatment with a high dose of BGS649	1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules.
BGS649 low dose	Active treatment with a low dose of BGS649	1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger	8 months	Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic Profile of BGS649 as Described by Cmax	8 hours	The peak plasma concentration of BGS649 after dosing at cycle 2 and cycle 4. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occured at pre-dose, 0.5-1.5h and 4-8 h post-dose.
Pharmacokinetic Profille of BGS649 as Described by AUC0-672h	8 hours	AUC0-672 is a measurement of how much drug reaches a person's bloodstream in a given period of time after a dose is given. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occured at pre-dose, 0.5-1.5h and 4-8 h post-dose.
Pharmacokinetic Profile of BGS649 as Described by Tmax	8 hours	Time taken to reach the maximum concentration in plasma of BGS649 at cycle 2 and cycle 4. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occurred at pre-dose, 0.5-1.5h and 4-8 h post-dose.