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

Mereo BioPharma

Status and phase: Terminated; Phase 2

Conditions: Pelvic Pain Associated With Refractory Endometriosis

Treatments: Drug: Placebo; Drug: BGS649

Study type: Interventional

Funder types: Industry

Identifiers

NCT01116440

CBGS649A2202

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 2 patient groups, including a placebo group

BGS649 co-administered with Levora 28™

Experimental group

Treatment:

Drug: BGS649

Placebo co-administered with Levora 28™

Placebo Comparator group

Treatment:

Drug: Placebo