Clinical trial NCT02794467: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Adenomyosis
Keywords: Heavy menstrual bleeding
Adenomyosis
Safety
Epelsiban
Tolerability
Proof of concept
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-06-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Mean percent change from baseline in monthly menstrual blood loss (MBL) to menstrual Cycle 3
timeFrame: Baseline and end of menses Cycle 3 (approximately 12 weeks)
measure: Number of subjects with adverse events (AE)
timeFrame: Up to 3 months
Secondary outcomes:
measure: Change from baseline in monthly menstrual blood loss (MBL) at menstrual Cycle 1, 2, and 3
timeFrame: Baseline, and end of menses Cycle 1, 2, and 3 (approximately 12 weeks)
measure: Average daily dysmenorrhea score from Day -1 to Day 2 in each cycle
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Washington, DC
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Champaign
country: United States
facility: GSK Investigational Site
state: Illinois
city: Mandeville
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Lawrenceville
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Englewood
country: United States
facility: GSK Investigational Site
state: Ohio
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: