Trial of Mifepristone for Fibroids

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kevin Fiscella, University of Rochester
ClinicalTrials.gov Identifier:
NCT00133705
First received: August 22, 2005
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Leiomyoma
Drug: Mifepristone
Drug: Inert Capsule
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Control Trial Of Mifepristone for Fibroids

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Uterine Volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Uterine volume is measured in mLs


Enrollment: 70
Study Start Date: July 2003
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mifepristone
Mifepristone 5 MG capsule taken once daily by mouth
Drug: Mifepristone
Mifepristone 5mg/day by mouth for 6 months
Other Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133705

Locations
United States, New York
University of Rochester School of Medicine & Dentistry
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Kevin Fiscella, MD, MPH University of Rochester School of Medicine & Dentistry
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kevin Fiscella, Tenured Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00133705     History of Changes
Other Study ID Numbers: RO1-HD042578-2
Study First Received: August 22, 2005
Results First Received: November 1, 2012
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
A benign tumor derived from smooth uterine muscle tissue.

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Mifepristone
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on July 28, 2014