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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adenomyosis, Heavy Uterine Bleeding, Dysmenorrhea

Intervention / Treatment
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* Drug: Ulipristal Acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 51 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ulipristal<br>Ulipristal acetate 5mg daily for 12 weeks | Drug: Ulipristal Acetate<br>* Ulipristal 5mg daily by mouth for 12 weeks<br>* Other names: Fibristal;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heavy periods, painful periods, adenomyosis