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Ulipristal for Endometriosis-related Pelvic Pain

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ClinicalTrials.gov Identifier: NCT02213081
Recruitment Status : Unknown
Verified September 2016 by Serdar Bulun, Northwestern University.
Recruitment status was:  Active, not recruiting
First Posted : August 11, 2014
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Serdar Bulun, 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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
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

Resource links provided by the National Library of Medicine


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




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213081


Locations
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United States, Illinois
Northwestern University, Prentice Women's Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Serdar Bulun Northwestern University, Northwestern Memorial Hopsital

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Responsible Party: Serdar Bulun, Chair, Department of Obstetrics & Gynecology, Northwestern University
ClinicalTrials.gov Identifier: NCT02213081     History of Changes
Other Study ID Numbers: STU00091840
First Posted: August 11, 2014    Key Record Dates
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:
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Endometriosis
Pelvic Pain
Genital Diseases, Female
Pain
Neurologic Manifestations
Signs and Symptoms
Ulipristal acetate
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs