Ulipristal for Endometriosis-related Pelvic Pain

• ClinicalTrials.gov Identifier: NCT02213081
• Recruitment Status: Unknown
• First Posted: August 11, 2014
• Last Update Posted: September 29, 2016
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Serdar Bulun, Northwestern University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Endometriosis	Drug: Ulipristal	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase IV Pilot Study of Ulipristal Acetate for Treatment of Endometriosis-related Pelvic Pain
• Study Start Date: February 2015
• Estimated Primary Completion Date: June 2017
• Estimated Study Completion Date: June 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ulipristal; 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.	Drug: Ulipristal; Patients will take 15mg every other day, or every 4 days per week.; Other Names: Ulipristal Acetate; Ella

Outcome Measures

Primary Outcome Measures :

1. Pelvic Pain [ Time Frame: 5 months ]
   Patients will document self-reported weekly average pelvic pain scores for one month prior to starting treatment, while receiving treatment for 3 months and for one full month subsequent to treatment.

Secondary Outcome Measures :

1. Vaginal bleeding [ Time Frame: 5 months ]
   Patients will record the # of tampons or pads they use each week while enrolled in the study (1 month pre-medication, 3 months during medication, 1 month after medication).
2. Pain with sexual intercourse [ Time Frame: 5 months ]
   If sexually active, patients will document self-reported weekly average pelvic pain scores with sexual intercourse for one month prior to starting treatment, while receiving treatment for 3 months and for one full month subsequent to treatment.
3. Serum hormone levels [ Time Frame: 5 months ]
   Serum levels of hormones that regulate the menstrual cycle will be assessed one month prior to starting treatment, while receiving treatment for 3 months and at one month subsequent to treatment.

Other Outcome Measures:

1. Pain with bowel movements [ Time Frame: 5 months ]
   Patients will document self-reported weekly average pelvic pain scores with defecation for one month prior to starting treatment, while receiving treatment for 3 months and for one full month subsequent to treatment.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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/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.

Contacts and Locations

Locations

United States, Illinois

Northwestern University, Prentice Women's Hospital

Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators

• Principal Investigator: Serdar Bulun; Northwestern University, Northwestern Memorial Hopsital

More Information

• Responsible Party: Serdar Bulun, Chair, Department of Obstetrics & Gynecology, Northwestern University
• ClinicalTrials.gov Identifier: NCT02213081
• Other Study ID Numbers: STU00091840
• First Posted: August 11, 2014
• Last Update Posted: September 29, 2016
• Last Verified: September 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Serdar Bulun, Northwestern University:

Endometriosis; chronic pelvic pain; dysmenorrhea; dyschezia; bleeding; ulipristal; progesterone

Additional relevant MeSH terms:

Endometriosis; Pelvic Pain; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Ulipristal acetate; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Contraceptive Agents, Female