Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis

• Status: Withdrawn
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of the study is to assess the efficacy, safety, and tolerability of epelsiban compared with placebo in treatment of women with adenomyosis.

This is a 12-week, randomized, double-blind, placebo-controlled, parallel group study with an interim futility analysis. Subjects will be randomized 1:1:1 to receive 75 milligrams (mg) of epelsiban three times daily (TID), 200 mg of epelsiban TID, or placebo TID. The study will be composed of three periods: screening, treatment, and follow-up and the total time a subject will be in the study will be approximately 6 months.

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Diketopiperazines

Criteria

Inclusion Criteria:

• Eighteen to 55 years of age, inclusive

• Pre-menopausal with a history of regular menstrual cycles every 21-35 days and without intermenstrual bleeding heavier than spotting and staining.

• Females with adenomyosis confirmed on magnetic resonance imaging (MRI), - Females with heavy menstrual bleeding .

• Willing and able to collect all menstrual cycle by-products for each cycle from screening to follow up.

• Not pregnant as confirmed by a negative serum human chorionic gonadotropin

Exclusion Criteria:

• A female subject will not be eligible for inclusion in this study if any of the following criteria apply:

• Abnormal gynecological examination other than adenomyosis and/or breast examination requiring intervention within six months of study start

• Abnormal endometrial biopsy within six months of starting study treatment.

• History of an endometrial ablation within 12 months of starting study treatment.

• Uterine artery embolization within six months of starting study treatment.

• Prior major uterine procedures or any other significant uterine abnormalities on MRI (previous caesarean section, dilation and curettage, and diagnostic hysteroscopy are permitted).

• Confirmed rectovaginal endometriosis in women who have undergone a prior laparoscopy.

• Active pelvic infection or current use of an intrauterine device within three months of screening.

• Women with a history of transfusion for heavy menstrual bleeding within the past 2 years or history of postpartum hemorrhage.

• Any uterine dimension >20 centimeter (cm).

• Other major causes of heavy menstrual bleeding -

• Use within 3 months or anticipated use of medications that modify reproductive function

• Use or anticipated use of the following drugs: anticoagulants aminocaproic acid ,or any other medications that affect menstrual bleeding such as tranexamic acid.

• Use of daily opioid pain medications other than with menses.

• Hemoglobin <8 grams (g)/deciliter.

• History of bleeding disorder or known presence of acquired or inherited thrombophilia, (sickle cell trait individuals are not excluded).