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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
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
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.
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
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
Time frame: 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
Time frame: Up to 3 months
Change from baseline in monthly menstrual blood loss (MBL) at menstrual Cycle 1, 2, and 3
MBL will be measured from blood collected from menstrual cycle by-products
Time frame: 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
Average daily dysmenorrhea score from Day -1 to Day 2 of menses
Time frame: Up to 3 months
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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
...and 3 more locations