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

Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03325868
• Other study ID #: Ulipristal
• Status: Withdrawn
• Phase: Phase 4
• First received: October 25, 2017
• Last updated: February 6, 2018
• Start date: February 2018
• Est. completion date: May 2019

Study information

• Verified date: February 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 51 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis
• Dysmenorrhea
• Heavy Uterine Bleeding
• Hemorrhage
• Uterine Hemorrhage

Intervention

Drug:
• Ulipristal Acetate
Ulipristal 5mg daily by mouth for 12 weeks

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding patterns	Patient will use the pictorial blood loss assessment chart (PBAC) to describe bleeding patterns	6 months
Secondary	Quality of life	Patient will complete menorrhagia impact questionnaire (0-100, 0 is worst and 100 is best quality of life)	6 months
Secondary	Pain	Patient will complete pain scale (0-10, 0 is no pain and 10 is worst pain)	6 months