Trial of Mifepristone for Fibroids

September 5, 2023 updated by: Kevin Fiscella, University of Rochester

Randomized Control Trial Of Mifepristone for Fibroids

The purpose of this trial is to determine if low-dose mifepristone benefits women with symptomatic fibroids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This trial is designed to assess the efficacy and tolerability of mifepristone 5 mg given daily for 6 months to pre-menopausal women with symptomatic fibroids. The primary study outcome will be disease-specific quality of life. Secondary outcome measures include global quality of life, pain, bleeding, potential adverse effects, tumor size, and endometrial effects. The researchers will also examine a the effect of mifepristone on uterine blood flow. Randomization of study subjects will be stratified in order to ensure that equal numbers of women with moderate and severe symptoms will be enrolled in the placebo and control groups.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester School of Medicine & Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Gender: Female
  • Age: 18 - premenopausal
  • Have at least moderate symptoms of menorrhagia or pelvic pain/pressure
  • Have a total uterine volume greater than or equal to 160 cc by ultrasound measurement and at least one fibroid that is => 2.5cm in size
  • Have a score of equal to or greater than 39 on the Uterine Fibroid Symptom and Quality of Life scale
  • Declined standard treatment options for symptomatic fibroids
  • Agree to use a double-barrier method (condoms, diaphragms) or other effective non-hormonal methods of contraception (abstinence, sterilization) throughout participation in the study to prevent pregnancy and to report any exposure to pregnancy to the research staff immediately
  • Willing and able to give informed consent
  • Willing and able to comply with study requirements

Exclusion Criteria:

  • Current or planned pregnancy during the study period
  • Menopausal, as indicated by follicle stimulating hormone (FSH) level of the reference laboratory
  • Currently breast-feeding
  • Untreated abnormal pap smear
  • Presence of conditions other than fibroids contributing to pain and/or bleeding
  • Hemoglobin < 9.0 mg/dl
  • Presence of adnexal masses or tenderness indicating further evaluation or surgery
  • Grade III or IV hydronephrosis by ultrasound
  • Severe, active mental health disorder
  • Active substance abuse or dependence

  • Presence of any contraindication to mifepristone including:

    • Adrenal insufficiency by history
    • Sickle cell disease
    • Active liver disease (liver function tests greater than 1.5 times upper range of normal)
    • Severe, respiratory disease (P02 saturation< 92%)
    • Renal disease (serum creatinine > 1.5 mg/dl)
    • Blood clotting defect. (abnormal PT and PTT)
    • Thromboembolic disease (history of deep vein thrombosis or pulmonary embolus)

  • Current or recent (within the past 3 months) use of the following medications:

    • Oral or systemic corticosteroids
    • Hormones: estrogens, progestins, oral contraceptives
    • Danazol, anticoagulants
  • Herbal or botanical supplements with possible hormonal effects.
  • Use within the past six months of the gonadotropin releasing hormones (GnRH) analogs or Depo-Provera.

  • Current or planned use during the study of any of the following medications/or products:

    • ketoconazole,
    • itraconazole,
    • erythromycin,
    • grapefruit juice,
    • rifampin,
    • St John's Wort,
    • phenytoin,
    • phenobarbital, or
    • carbamazepine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mifepristone
Mifepristone 5 MG capsule taken once daily by mouth
Drug: Mifepristone
Mifepristone 5mg/day by mouth for 6 months
Other Names:
  • RU486
Placebo Comparator: Inert capsule
Placebo (for Mifepristone) capsule of nearly identical color, size, and weight taken once daily by mouth
Drug: Inert Capsule
sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uterine Volume
Time Frame: 6 months
Uterine volume is measured in mLs
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Kevin Fiscella, MD, MPH, University of Rochester School of Medicine & Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

August 22, 2005

First Submitted That Met QC Criteria

August 22, 2005

First Posted (Estimated)

August 23, 2005

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RO1-HD042578-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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