BGS649 Monotherapy in Moderate to Severe Endometriosis Patients

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mereo BioPharma; Novartis
• Collaborator: Novartis

Criteria

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