Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis
| Status: | Withdrawn |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 51 |
| Updated: | 2/10/2018 |
| Start Date: | February 2018 |
| End Date: | May 2019 |
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.
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.
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.
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
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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