Status:
WITHDRAWN
Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Adenomyosis
Heavy Uterine Bleeding
Eligibility:
FEMALE
18-51 years
Phase:
PHASE4
Brief Summary
Adenomyosis affects approximately 21% of symptomatic women who present to gynecology clinics. The disease is characterized by heavy bleeding and pain during periods. Limited treatment options exist fo...
Detailed Description
Adenomyosis affects an estimated 20.9% of symptomatic women who present to gynecology clinics, with peak prevalence of 32% in 40-49 years old. Prior histologic studies in women undergoing hysterectomy...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 18-51 years old
- PBAC score greater than 100
- Ultrasound or MRI findings of adenomyosis
- Exclusion Criteria
- Inability to comprehend written and/or spoken English or Spanish
- Inability to provide informed consent
- Current uterine, breast, cervical or ovarian cancer
- Unwilling to use contraception
- Positive pregnancy test or planning pregnancy during the study period
- Submucosal uterine fibroids (or greater than a certain size)
- Current premalignancy or malignancy
- Endometrial ablation or uterine artery embolization
- Known hemoglobinopathy
- Known severe coagulation disorder
- Large uterine polyp (\>2cm)
- BMI \>40
- Previous or current treatment with SPRM or GnRH agonist
- Progestins, acetylsalicylic acid, mefenamic acid, anticoagulants, antifibrinolytic drugs, systemic glucocorticoids within 1 month of enrollment
Exclusion
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03325868
Start Date
February 1 2018
End Date
May 1 2019
Last Update
February 8 2018
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232