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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Adenomyosis

In brief

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.

Key facts

Study ID

NCT02794467

Run by

GlaxoSmithKline

People needed

0

Starts

2016-07-01

Expected to finish

2016-10-01

Last updated by the study team

2017-01-18

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

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…

• 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).

Where it is running

• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — West Palm Beach, Florida, United States
• GSK Investigational Site — Champaign, Illinois, United States
• GSK Investigational Site — Mandeville, Louisiana, United States
• GSK Investigational Site — Metairie, Louisiana, United States
• GSK Investigational Site — Lincoln, Nebraska, United States
• GSK Investigational Site — Las Vegas, Nevada, United States
• GSK Investigational Site — Lawrenceville, New Jersey, United States
• GSK Investigational Site — Durham, North Carolina, United States
• GSK Investigational Site — Raleigh, North Carolina, United States
• GSK Investigational Site — Englewood, Ohio, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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