Ulipristal for Endometriosis-related Pelvic Pain

Phase 4

Completed

Conditions: Endometriosis

Interventions: Drug: Ulipristal

Registration Number: NCT02213081

Lead Sponsor: Northwestern University

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 1

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ulipristal	Ulipristal	1 patient 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.

Primary Outcome Measures

Name	Time	Method
Pelvic Pain	Patients will document self-reported daily pain scores via visual analogue scale(0 to10 where 0 is no pain and 10 is worst pain)for one month prior to starting treatment (1 month),while receiving treatment (3 months) after cessation of treatment (1 month)	Scores were collected daily and averaged together for each period

Secondary Outcome Measures

Name	Time	Method
Vaginal Bleeding	5 months	Patient 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).
Pain With Sexual Intercourse	5 months	If sexually active, patients will document self-reported weekly average pelvic pain scores (0 to 10 where 0 is no pain and 10 is worst pain) with sexual intercourse for one month prior to starting treatment, while receiving treatment for 3 months and for one full month subsequent to treatment.