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Ulipristal for Endometriosis-related Pelvic Pain

Information source: Northwestern University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Endometriosis

Intervention: Ulipristal (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Northwestern University

Official(s) and/or principal investigator(s):
Serdar Bulun, Principal Investigator, Affiliation: Northwestern University, Northwestern Memorial Hopsital

Overall contact:
Serdar Bulun, MD, Phone: 312-472-3636, Email: sbulun@nmh.org

Summary

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.

Clinical Details

Official title: Phase IV Pilot Study of Ulipristal Acetate for Treatment of Endometriosis-related Pelvic Pain

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pelvic Pain

Secondary outcome:

Vaginal bleeding

Pain with sexual intercourse

Serum hormone levels

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

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/mcL

- absolute neutrophil count ≥ 1,500/mcL

- platelets ≥ 100,000/mcl

- 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.

Locations and Contacts

Serdar Bulun, MD, Phone: 312-472-3636, Email: sbulun@nmh.org

Northwestern University, Prentice Women's Hospital, Chicago, Illinois 60611, United States; Recruiting
Serdar Bulun, MD
Additional Information

Starting date: February 2015
Last updated: February 10, 2015

Page last updated: August 20, 2015

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