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

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Adenomyosis
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Brief Title

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

Official Title

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

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 Phase

Phase 4

Study Type

Interventional

Primary Outcome

Bleeding patterns

Secondary Outcome

 Quality of life

Condition

Adenomyosis

Intervention

Ulipristal Acetate

Study Arms / Comparison Groups

 Ulipristal
Description:  Ulipristal acetate 5mg daily for 12 weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

0

Start Date

February 2018

Completion Date

May 2019

Primary Completion Date

May 2019

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

Gender

Female

Ages

18 Years - 51 Years

Accepts Healthy Volunteers

No

Contacts

Amanda Yunker, DO, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03325868

Organization ID

Ulipristal

Responsible Party

Principal Investigator

Study Sponsor

Vanderbilt University Medical Center

Study Sponsor

Amanda Yunker, DO, Study Director, Vanderbilt University Medical Center

Verification Date

February 2018