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

NCT02794467 | Withdrawn Phase 2

• 1 other identifier: 201580
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 13

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.

Conditions

Adenomyosis

Keywords

Heavy menstrual bleeding; Adenomyosis; Safety; Epelsiban; Tolerability; Proof of concept

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (2)

• 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)

• Average daily dysmenorrhea score from Day -1 to Day 2 in each cycle

  Up to 3 months

Study Arms (3)

Epelsiban 75 mg

EXPERIMENTAL

Approximately 24 subjects will receive 75 mg of epelsiban three times a day (TID) via oral administration

Drug: Epelsiban

Epelsiban 200 mg

EXPERIMENTAL

Approximately 24 subjects will receive 200 mg of epelsiban TID via oral administration

Drug: Epelsiban

Placebo

PLACEBO COMPARATOR

Approximately 24 subjects will receive a matching placebo TID via oral administration

Drug: Placebo

Interventions

Epelsiban DRUG

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

Epelsiban 200 mg; Epelsiban 75 mg

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (13)

GSK Investigational Site

Washington D.C., District of Columbia, 20036, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33409, United States

Location

GSK Investigational Site

Champaign, Illinois, 61820, United States

Location

GSK Investigational Site

Mandeville, Louisiana, 70471, United States

Location

GSK Investigational Site

Metairie, Louisiana, 70006, United States

Location

GSK Investigational Site

Lincoln, Nebraska, 68510, United States

Location

GSK Investigational Site

Las Vegas, Nevada, 89128, United States

Location

GSK Investigational Site

Lawrenceville, New Jersey, 08648, United States

Location

GSK Investigational Site

Durham, North Carolina, 27713, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27612, United States

Location

GSK Investigational Site

Englewood, Ohio, 45322, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15206, United States

Location

GSK Investigational Site

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Adenomyosis; Menorrhagia

Interventions

epelsiban

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 9, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

US (13)