Ulipristal for Endometriosis-related Pelvic Pain

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

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.

Study Overview

• Status: Unknown
• Conditions: Endometriosis
• Intervention / Treatment: Drug: Ulipristal

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 Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University, Prentice Women's Hospital

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: Ella; Ulipristal Acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic Pain	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.	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal bleeding	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).	5 months
Pain with sexual intercourse	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.	5 months
Serum hormone levels	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.	5 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain with bowel movements	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.	5 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Serdar Bulun, Northwestern University, Northwestern Memorial Hopsital

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: August 7, 2014
• First Submitted That Met QC Criteria: August 8, 2014
• First Posted (Estimate): August 11, 2014

Study Record Updates

• Last Update Posted (Estimate): September 29, 2016
• Last Update Submitted That Met QC Criteria: September 27, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: bleeding; Endometriosis; progesterone; dysmenorrhea; chronic pelvic pain; dyschezia; ulipristal
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Endometriosis; Pelvic Pain; Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Ulipristal acetate
• Other Study ID Numbers: STU00091840

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No