Last updated: 11/03/2018 21:45:29
Placebo-controlled proof of concept study of epelsiban in women with adenomyosis
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
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)
Number of subjects with adverse events (AE)
Timeframe: Up to 3 months
Secondary outcomes:
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)
Average daily dysmenorrhea score from Day -1 to Day 2 in each cycle
Timeframe: Up to 3 months
Interventions:
Enrollment:
0
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Adenomyosis
Product
epelsiban
Collaborators
Not applicable
Study date(s)
July 2016 to October 2016
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
18 - 55 years
Accepts healthy volunteers
No
- 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.
- 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
Inclusion and exclusion 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).
Trial location(s)
Location
GSK Investigational Site
Washington, DC, District of Columbia, United States, 20036
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Champaign, Illinois, United States, 61820
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lincoln, Nebraska, United States, 68510
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70006
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
Status
Study Complete
Showing 1 - 6 of 13 Results
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
2016-28-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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