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

NCT ID: NCT03325868

Last Updated: 2018-02-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2019-05-31

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.

Conditions

Adenomyosis; Heavy Uterine Bleeding; Dysmenorrhea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ulipristal

Ulipristal acetate 5mg daily for 12 weeks

Group Type: EXPERIMENTAL

Ulipristal Acetate

Intervention Type: DRUG

Ulipristal 5mg daily by mouth for 12 weeks

Interventions

Ulipristal Acetate

Ulipristal 5mg daily by mouth for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Fibristal

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 51 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Cynthia Arvizo

Clinical Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amanda Yunker, DO

Role: STUDY_DIRECTOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

Ulipristal

Identifier Type: -

Identifier Source: org_study_id