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

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ClinicalTrials.gov Identifier: NCT02794467
Recruitment Status : Withdrawn (Study was prematurely discontinued due to GSK's change in prioritization for the portfolio and is not due to any safety concerns or regulatory interaction.)
First Posted : June 9, 2016
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Adenomyosis Drug: Epelsiban Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : July 2016
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: Epelsiban 75 mg
Approximately 24 subjects will receive 75 mg of epelsiban three times a day (TID) via oral administration
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

Experimental: Epelsiban 200 mg
Approximately 24 subjects will receive 200 mg of epelsiban TID via oral administration
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 Comparator: Placebo
Approximately 24 subjects will receive a matching placebo TID via oral administration
Drug: 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.




Primary Outcome Measures :
  1. Mean percent change from baseline in monthly menstrual blood loss (MBL) to menstrual Cycle 3 [ Time Frame: 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

  2. Number of subjects with adverse events (AE) [ Time Frame: 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 :
  1. Change from baseline in monthly menstrual blood loss (MBL) at menstrual Cycle 1, 2, and 3 [ Time Frame: 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

  2. Average daily dysmenorrhea score from Day -1 to Day 2 in each cycle [ Time Frame: Up to 3 months ]
    Average daily dysmenorrhea score from Day -1 to Day 2 of menses



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794467


Locations
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United States, District of Columbia
GSK Investigational Site
Washington, DC, District of Columbia, United States, 20036
United States, Florida
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
United States, Illinois
GSK Investigational Site
Champaign, Illinois, United States, 61820
United States, Louisiana
GSK Investigational Site
Mandeville, Louisiana, United States, 70471
GSK Investigational Site
Metairie, Louisiana, United States, 70006
United States, Nebraska
GSK Investigational Site
Lincoln, Nebraska, United States, 68510
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89128
United States, New Jersey
GSK Investigational Site
Lawrenceville, New Jersey, United States, 08648
United States, North Carolina
GSK Investigational Site
Durham, North Carolina, United States, 27713
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
GSK Investigational Site
Englewood, Ohio, United States, 45322
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15206
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02794467     History of Changes
Other Study ID Numbers: 201580
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017

Keywords provided by GlaxoSmithKline:
Heavy menstrual bleeding
Adenomyosis
Safety
Epelsiban
Tolerability
Proof of concept

Additional relevant MeSH terms:
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Adenomyosis
Uterine Diseases
Genital Diseases, Female
Diketopiperazines
Anti-Bacterial Agents
Anti-Infective Agents