Adenomyosis
Conditions
Keywords
Heavy menstrual bleeding, Adenomyosis, Safety, Epelsiban, Tolerability, Proof of concept
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.
Interventions
DRUGEpelsiban
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
DRUGPlacebo
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.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean percent change from baseline in monthly menstrual blood loss (MBL) to menstrual Cycle 3 | 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 |
| Number of subjects with adverse events (AE) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in monthly menstrual blood loss (MBL) at menstrual Cycle 1, 2, and 3 | 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 |
| Average daily dysmenorrhea score from Day -1 to Day 2 in each cycle | Up to 3 months | Average daily dysmenorrhea score from Day -1 to Day 2 of menses |
Countries
United States
Outcome results
None listed