Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis
Withdrawn before enrolling · Phase 4
Conditions studied: Adenomyosis, Heavy Uterine Bleeding, Dysmenorrhea
In brief
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 for the treatment of adenomyosis for women who desire future child-bearing or prefer to avoid surgery. Recently, ulipristal acetate has been studied as a treatment option for women who have fibroids and heavy bleeding. The majority of women treated with ulipristal stopped having periods altogether. Our study aims to determine whether ulipristal is an adequate treatment for women with adenomyosis.
Key facts
- Study ID
- NCT03325868
- Run by
- Vanderbilt University Medical Center
- People needed
- 0
- Starts
- 2018-02-01
- Expected to finish
- 2019-05-01
- Last updated by the study team
- 2018-02-08
Who can join
Age: 18 and older, up to 51. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 18-51 years old
- PBAC score greater than 100
- Ultrasound or MRI findings of adenomyosis
You may not qualify if…
- 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
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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