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BGS649 Monotherapy in Moderate to Severe Endometriosis Patients
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Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger [ Time Frame: 8 months ]
Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger.
Secondary Outcome Measures
Measure: To Evaluate the Pharmacokinetic Profile of BGS649 Following Multiple Dosing at Two Dose Levels Over 3 Months in Pre-menopausal Women With Moderate to Severe Endometriosis. [ Time Frame: 8 months (Assess PK profile from first dosing through end of study and compare PK on Day 1 of first dose to that of third month) ]
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Ages Eligible for Study:
18 Years to 40 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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