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

Phase 2

Withdrawn

• Conditions: Adenomyosis
• Interventions: Drug: Epelsiban; Drug: Placebo

• Registration Number: NCT02794467
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-06-06
• Study First Posted: 2016-06-09
• Study Start: 2016-07
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epelsiban 75 mg	Epelsiban	Approximately 24 subjects will receive 75 mg of epelsiban three times a day (TID) via oral administration
Epelsiban 200 mg	Epelsiban	Approximately 24 subjects will receive 200 mg of epelsiban TID via oral administration
Placebo	Placebo	Approximately 24 subjects will receive a matching placebo TID via oral administration

Primary Outcome Measures

Name	Time	Method
Mean percent change from baseline in monthly menstrual blood loss (MBL) to menstrual Cycle 3	Baseline and end of menses Cycle 3 (approximately 12 weeks)	MBL will be measured from blood collected from menstrual cycle by-products and recovered by alkaline hematin method during each menstrual cycle
Number of subjects with adverse events (AE)	Up to 3 months	An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product; safety and tolerability as assessed by incidence of adverse events

Secondary Outcome Measures

Name	Time	Method
Average daily dysmenorrhea score from Day -1 to Day 2 in each cycle	Up to 3 months	Average daily dysmenorrhea score from Day -1 to Day 2 of menses
Change from baseline in monthly menstrual blood loss (MBL) at menstrual Cycle 1, 2, and 3	Baseline, and end of menses Cycle 1, 2, and 3 (approximately 12 weeks)	MBL will be measured from blood collected from menstrual cycle by-products

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Houston, Texas, United States