Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis

• Status: Withdrawn
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: Ulipristal acetate

Criteria

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