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

Vanderbilt University Medical Center

Status and phase

Withdrawn

Phase 4

Conditions

Dysmenorrhea

Heavy Uterine Bleeding

Adenomyosis

Treatments

Drug: Ulipristal Acetate

Study type

Interventional

Funder types

Other

Identifiers

NCT03325868

Ulipristal

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18 to 51 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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