This trial is active, not recruiting.

Condition endometriosis
Treatment ulipristal
Phase phase 4
Sponsor Northwestern University
Start date February 2015
End date June 2017
Trial size 25 participants
Trial identifier NCT02213081, STU00091840


The aim of this research is to assess the benefit of a medication (ulipristal) for alleviation of symptoms in women with chronic, endometriosis-related pelvic pain.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
25 patients with chronic, endometriosis-related pelvic pain refractory to medical and/or surgical therapies will receive 15mg ulipristal every other day (three times a week- Monday, Thursday, Saturday) for three months.
ulipristal Ulipristal Acetate
Patients will take 15mg every other day, or every 4 days per week.

Primary Outcomes

Pelvic Pain
time frame: 5 months

Secondary Outcomes

Vaginal bleeding
time frame: 5 months
Pain with sexual intercourse
time frame: 5 months
Serum hormone levels
time frame: 5 months

Eligibility Criteria

Female participants from 18 years up to 50 years old.

Inclusion Criteria: - Diagnosis of endometriosis with surgical confirmation via laparoscopy performed within 3 years prior to study enrollment - English-speaking reproductive-age women (18-50yo) with regular, cyclical menses - Treatment-refractory endometriosis, as defined by persistent or recurrent pelvic pain following one or more treatments involving surgery and/or hormonal treatment - Dysmenorrhea and chronic pelvic pain for a least one week out of the month during past 5 months or longer - Endometrial biopsy before and after intervention - Adequate organ and marrow function as defined below: - leukocytes ≥ 3,000/microliter - absolute neutrophil count ≥ 1,500/microliter - platelets ≥ 100,000/microliter - total bilirubin within normal institutional limits - Liver function tests ≤ 2.5 X institutional upper limit of normal - creatinine within normal institutional limits - Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. - A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: - Has not undergone a hysterectomy or bilateral oophorectomy; or - Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). - Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: - Undiagnosed vaginal bleeding - Abnormal results from endometrial biopsy - Presence of ovarian cysts ≥ 3 cm - Pregnancy - Refusal to adhere the birth control strategy of the study (use of a combination of a condom and a vaginal sponge during each intercourse while on ulipristal, plus one month before the onset and one month after the completion of ulipristal therapy) - Women taking digoxin, dabigatran or etexilate due to interference of ulipristal acetate with the concentration of these substances bound by plasma proteins. - Women taking moderate to potent inducers of hepatic metabolism (e.g. erythromycin, ketoconazole, ritonavir, nefazodone). - History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ulipristal. - Uncontrolled intercurrent illness including, but not limited to, ongoing or active pulmonary, cardiac, renal, hepatic or thromboembolic disease, infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Additional Information

Official title Phase IV Pilot Study of Ulipristal Acetate for Treatment of Endometriosis-related Pelvic Pain
Principal investigator Serdar Bulun
Description This study will assess the use of a medication to improve symptoms of chronic, endometriosis-related pelvic pain among women who did no achieve relief with prior surgical and medical treatments.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Northwestern University.