Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis
NCT ID: NCT02794467
Last Updated: 2017-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2016-07-31
2016-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Epelsiban 75 mg
Approximately 24 subjects will receive 75 mg of epelsiban three times a day (TID) via oral administration
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
Epelsiban 200 mg
Approximately 24 subjects will receive 200 mg of epelsiban TID via oral administration
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
Approximately 24 subjects will receive a matching placebo TID via oral administration
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
55 Years
FEMALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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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
Countries
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Other Identifiers
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201580
Identifier Type: -
Identifier Source: org_study_id
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