Trial of Mifepristone for Fibroids

NCT00133705 | Completed Phase 3 Results DMC

• 2 other identifiers: RO1-HD042578-2R01HD042578
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Leiomyoma

Keywords

A benign tumor derived from smooth uterine muscle tissue.

Outcome Measures

Primary Outcomes (1)

• Uterine Volume

  Uterine volume is measured in mLs

  6 months

Study Arms (2)

Mifepristone

EXPERIMENTAL

Mifepristone 5 MG capsule taken once daily by mouth

Drug: Mifepristone

Inert capsule

PLACEBO COMPARATOR

Placebo (for Mifepristone) capsule of nearly identical color, size, and weight taken once daily by mouth

Drug: Inert Capsule

Interventions

Mifepristone DRUG

Mifepristone 5mg/day by mouth for 6 months

Also known as: RU486

Mifepristone

Inert Capsule DRUG

sugar pill

Inert capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• University of Rochester: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Rochester School of Medicine & Dentistry

Rochester, New York, 14642, United States

Location

Related Publications (3)

• Eisinger SH, Bonfiglio T, Fiscella K, Meldrum S, Guzick DS. Twelve-month safety and efficacy of low-dose mifepristone for uterine myomas. J Minim Invasive Gynecol. 2005 May-Jun;12(3):227-33. doi: 10.1016/j.jmig.2005.01.022.

  PMID: 15922980 BACKGROUND

• Eisinger SH, Meldrum S, Fiscella K, le Roux HD, Guzick DS. Low-dose mifepristone for uterine leiomyomata. Obstet Gynecol. 2003 Feb;101(2):243-50. doi: 10.1016/s0029-7844(02)02511-5.

  PMID: 12576246 BACKGROUND

• Fiscella K, Eisinger SH, Meldrum S, Feng C, Fisher SG, Guzick DS. Effect of mifepristone for symptomatic leiomyomata on quality of life and uterine size: a randomized controlled trial. Obstet Gynecol. 2006 Dec;108(6):1381-7. doi: 10.1097/01.AOG.0000243776.23391.7b.

  PMID: 17138770 DERIVED

MeSH Terms

Conditions

Leiomyoma

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

There were no adverse events in this clinical trial.

Results Point of Contact

• Title: Dr. Kevin Fiscella
• Organization: University of Rochester

kevin_fiscella@urmc.rochester.edu

585-271-1206

Study Officials

• Kevin Fiscella, MD, MPH

  University of Rochester School of Medicine & Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenured Professor

Study Record Dates

• First Submitted: August 22, 2005
• First Posted: August 23, 2005
• Study Start: July 1, 2003
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 25, 2023
• Results First Posted: November 30, 2012

Record last verified: 2023-09

Locations

US (1)