Ulipristal for Endometriosis-related Pelvic Pain

NCT02213081 | Completed Phase 4 Results

• 1 other identifier: STU00091840
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pelvic Pain

  Scores were collected daily and averaged together for each period

  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)

Secondary Outcomes (2)

• Vaginal Bleeding

  5 months

• Pain With Sexual Intercourse

  5 months

Other Outcomes (1)

• Pain With Bowel Movements

  Patient will document self-reported daily pain scores via visual analogue scale(0 to 10 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)

Study Arms (1)

Ulipristal

EXPERIMENTAL

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.

Drug: Ulipristal

Interventions

Ulipristal DRUG

Patient will take 15mg every other day, or every 4 days per week.

Also known as: Ulipristal Acetate, Ella

Ulipristal

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University, Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Endometriosis; Dysmenorrhea; Constipation; Hemorrhage

Interventions

ulipristal; ulipristal acetate

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive

Results Point of Contact

• Title: Dr. Serdar Bulun
• Organization: Northwestern University

Serdar.Bulun@nm.org

312-472-3980

Study Officials

• Serdar Bulun

  Northwestern University, Northwestern Memorial Hopsital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 11, 2014
• Study Start: February 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)