Dysmenorrhea Clinical Trial
Official title:
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.
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.
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