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

Phase 4

Withdrawn

• Conditions: Adenomyosis; Heavy Uterine Bleeding; Dysmenorrhea
• Interventions: Drug: Ulipristal Acetate

• Registration Number: NCT03325868
• Lead Sponsor: Vanderbilt University Medical Center

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 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.

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 show prevalence of with some variation due to differing histologic diagnostic criteria 10-37.1%. Heavy menstrual bleeding and dysmenorrhea are commonly manifested in women with adenomyosis. However, data on treatment of adenomyosis remains scarce. For women desiring definitive options, hysterectomy remains the treatment of choice. However, for women who desire future fertility, the currently accepted first-line therapy is progestogen therapy, particularly the levonorgestrel-IUD. Other limited studies have used danazol and GnRH agonists, but its use is limited by significant side effects.

Recently, the selective progesterone receptor modulators (SPRM) have emerged as successful medical treatment options for leiomyoma. The SPRM ulipristal acetate has been studied extensively in the treatment of leiomyoma and more recently endometriosis. Ulipristal acetate exerts both antagonist and agonist properties. Amenorrhea was achieved in 80% of women taking 5mg of ulipristal daily by treatment month 2 and up to 90% of women taking 10mg daily. Anovulation was achieved in 80% of women taking 5mg and 10mg dosing. Ulipristal acetate has not been studied as a treatment option for women with adenomyosis. We aim to study the effect of daily ulipristal on heavy menstrual bleeding in women with adenomyosis.

Study Timeline

• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-30
• Status Verified: 2018-02
• Study Start: 2018-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-08
• Primary Completion: 2019-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ulipristal	Ulipristal Acetate	Ulipristal acetate 5mg daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Bleeding patterns	6 months	Patient will use the pictorial blood loss assessment chart (PBAC) to describe bleeding patterns

Secondary Outcome Measures

Name	Time	Method
Pain	6 months	Patient will complete pain scale (0-10, 0 is no pain and 10 is worst pain)
Quality of life	6 months	Patient will complete menorrhagia impact questionnaire (0-100, 0 is worst and 100 is best quality of life)

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States