BGS649 Monotherapy in Moderate to Severe Endometriosis Patients

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

Official Title
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A Randomized, Double-blind, Double-dummy, Placebo-controlled Study of Oral BGS649 Monotherapy Assessing Safety and Tolerability in Patients With Moderate to Severe Endometriosis

Conditions
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Endometriosis

Intervention / Treatment
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* Drug: Active treatment with a high dose of BGS649
* Drug: Active treatment with a low dose of BGS649
* Drug: Placebo treatment to blind study


Participation Criteria
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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. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BGS649 high dose<br>1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules. | Drug: Active treatment with a high dose of BGS649<br> <br> |
| Experimental: BGS649 low dose<br>1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules | Drug: Active treatment with a low dose of BGS649<br> <br> |
| Placebo Comparator: Placebo to BGS649<br>1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules | Drug: Placebo treatment to blind study<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger | Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Profille of BGS649 as Described by AUC0-672h | 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. | 8 hours | 
| Pharmacokinetic Profile of BGS649 as Described by Cmax | 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. | 8 hours | 
| Pharmacokinetic Profile of BGS649 as Described by Tmax | 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. | 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis, Infertility, Pain, Vaginal Diseases, Uterine Diseases