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

Adenomyosis Clinical Trial

Official title:

A Phase II, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Proof of Concept Study With an Interim Futility Analysis of Epelsiban in Patients With Adenomyosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02794467
• Other study ID #: 201580
• Status: Withdrawn
• Phase: Phase 2
• First received: June 6, 2016
• Last updated: January 16, 2017
• Start date: July 2016
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Adenomyosis

Intervention

Drug:
• Epelsiban
Epelsiban will be supplied as modified capsule shaped, white coated, oral tablet with a unit dose strength of 25 or 150 mg; to be taken with food or immediately after a meal, without chewing
• Placebo
A matching placebo will be supplied as modified capsule shaped, white coated, oral tablet; to be taken with food or immediately after a meal, without chewing.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Champaign	Illinois
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Englewood	Ohio
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Lawrenceville	New Jersey
United States	GSK Investigational Site	Lincoln	Nebraska
United States	GSK Investigational Site	Mandeville	Louisiana
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Washington, DC	District of Columbia
United States	GSK Investigational Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean percent change from baseline in monthly menstrual blood loss (MBL) to menstrual Cycle 3	MBL will be measured from blood collected from menstrual cycle by-products and recovered by alkaline hematin method during each menstrual cycle	Baseline and end of menses Cycle 3 (approximately 12 weeks)
Primary	Number of subjects with adverse events (AE)	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	Up to 3 months
Secondary	Change from baseline in monthly menstrual blood loss (MBL) at menstrual Cycle 1, 2, and 3	MBL will be measured from blood collected from menstrual cycle by-products	Baseline, and end of menses Cycle 1, 2, and 3 (approximately 12 weeks)
Secondary	Average daily dysmenorrhea score from Day -1 to Day 2 in each cycle	Average daily dysmenorrhea score from Day -1 to Day 2 of menses	Up to 3 months