Status:
WITHDRAWN
Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis
Lead Sponsor:
GlaxoSmithKline
Conditions:
Adenomyosis
Eligibility:
FEMALE
18-55 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02794467
Start Date
July 1 2016
End Date
October 1 2016
Last Update
January 18 2017
Active Locations (13)
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1
GSK Investigational Site
Washington D.C., District of Columbia, United States, 20036
2
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
3
GSK Investigational Site
Champaign, Illinois, United States, 61820
4
GSK Investigational Site
Mandeville, Louisiana, United States, 70471