Trial of Mifepristone for Fibroids

NCT ID: NCT00133705

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2010-06-30

Brief Summary

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

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.

Conditions

Leiomyoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Mifepristone

Mifepristone 5 MG capsule taken once daily by mouth

Group Type: EXPERIMENTAL

Mifepristone

Intervention Type: DRUG

Mifepristone 5mg/day by mouth for 6 months

Inert capsule

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

Group Type: PLACEBO_COMPARATOR

Inert Capsule

Intervention Type: DRUG

sugar pill

Interventions

Mifepristone

Mifepristone 5mg/day by mouth for 6 months

Intervention Type: DRUG

Inert Capsule

sugar pill

Intervention Type: DRUG

Other Intervention Names

RU486

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Kevin Fiscella

Tenured Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin Fiscella, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Rochester School of Medicine & Dentistry

Locations

University of Rochester School of Medicine & Dentistry

Rochester, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15922980 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12576246 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 17138770 (View on PubMed)

Other Identifiers

R01HD042578

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RO1-HD042578-2

Identifier Type: -

Identifier Source: org_study_id