A Safety & Efficacy Study of BGS649 in Women With Refractory Endometriosis

• Status: Terminated
• Trial end date: 2012-03-21
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine efficacy, safety, tolerability and pharmacokinetics of multiple doses of BGS649 with concurrent daily administration of combined oral contraception in patients with refractory endometriosis

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

Details

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

Criteria

Inclusion Criteria:

• Must have surgical diagnosis of endometriosis est. w/in 5 years before screening. Subjects must have self reported moderate to severe pelvic pain at screening to be confirmed during the run-in-phase

• Subjects with moderate to severe pelvic pain who were refractory to surgery (persistent or recurrent pelvic pain within 24 months after any therapeutic surgery) and at least two hormonal therapies from two different classes, including one approved hormonal therapy

Exclusion Criteria:

• Subjects who have undergone hysterectomy or bilateral oophorectomy.

• Surgical treatment of endometriosis within 3 months before screening.

• Subjects who are pregnant or who were pregnant within 3 months of visit one.

• Subjects who are nursing or lactating

• Subjects who are tobacco smokers.

Other protocol-defined inclusion/exclusion criteria may apply