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

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Brief Title

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

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

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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Mean percent change from baseline in monthly menstrual blood loss (MBL) to menstrual Cycle 3

Secondary Outcome

 Change from baseline in monthly menstrual blood loss (MBL) at menstrual Cycle 1, 2, and 3

Condition

Adenomyosis

Intervention

Epelsiban

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

0

Start Date

July 2016

Completion Date

October 2016

Primary Completion Date

October 2016

Eligibility 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).

Gender

Female

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

No

Contacts

GSK Clinical Trials, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02794467

Organization ID

201580

Responsible Party

Sponsor

Study Sponsor

GlaxoSmithKline

Study Sponsor

GSK Clinical Trials, Study Director, GlaxoSmithKline

Verification Date

January 2017