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

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03325868

Collaborator

(none)

Enrollment

Location

Arm

14.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adenomyosis Heavy Uterine Bleeding Dysmenorrhea	Drug: Ulipristal Acetate	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2018

Anticipated Primary Completion Date :

May 1, 2019

Anticipated Study Completion Date :

May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ulipristal Ulipristal acetate 5mg daily for 12 weeks	Drug: Ulipristal Acetate Ulipristal 5mg daily by mouth for 12 weeks Other Names: Fibristal

Arm

Intervention/Treatment

Experimental: Ulipristal

Ulipristal acetate 5mg daily for 12 weeks

Drug: Ulipristal Acetate

Ulipristal 5mg daily by mouth for 12 weeks

Other Names:

Fibristal

Outcome Measures

Primary Outcome Measures

Bleeding patterns [6 months]
Patient will use the pictorial blood loss assessment chart (PBAC) to describe bleeding patterns

Secondary Outcome Measures

Quality of life [6 months]
Patient will complete menorrhagia impact questionnaire (0-100, 0 is worst and 100 is best quality of life)
Pain [6 months]
Patient will complete pain scale (0-10, 0 is no pain and 10 is worst pain)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 51 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

Vanderbilt University Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cynthia Arvizo, Clinical Instructor, Vanderbilt University Medical Center

ClinicalTrials.gov Identifier:

NCT03325868

Other Study ID Numbers:

Ulipristal

First Posted:

Oct 30, 2017

Last Update Posted:

Feb 8, 2018

Last Verified:

Feb 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Cynthia Arvizo, Clinical Instructor, Vanderbilt University Medical Center

heavy periods, painful periods, adenomyosis

Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 8, 2018