Ulipristal for Endometriosis-related Pelvic Pain (NCT02213081) | Clinical Trial Compass
CompletedPhase 4
Ulipristal for Endometriosis-related Pelvic Pain
United States1 participantsStarted 2015-02
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Pelvic Pain
Timeframe: 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)