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

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.

Study Overview

• Status: Withdrawn
• Conditions: Dysmenorrhea; Adenomyosis; Heavy Uterine Bleeding
• Intervention / Treatment: Drug: Ulipristal Acetate

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ulipristal; Ulipristal acetate 5mg daily for 12 weeks	Drug: Ulipristal Acetate; Ulipristal 5mg daily by mouth for 12 weeks; Other Names: Fibristal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding patterns	Patient will use the pictorial blood loss assessment chart (PBAC) to describe bleeding patterns	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Study Director: Amanda Yunker, DO, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2018
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Actual): February 8, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: heavy periods, painful periods, adenomyosis
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Uterine Diseases; Menstruation Disturbances; Pelvic Pain; Hemorrhage; Dysmenorrhea; Adenomyosis; Uterine Hemorrhage; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Ulipristal acetate
• Other Study ID Numbers: Ulipristal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No