Trial of Mifepristone for Fibroids

Leiomyoma Clinical Trial

Official title:

Randomized Control Trial Of Mifepristone for Fibroids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00133705
• Other study ID #: RO1-HD042578-2
• Status: Completed
• Phase: Phase 3
• Start date: July 2003
• Est. completion date: June 2010

Study information

• Verified date: September 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma

Intervention

Drug:
• Mifepristone
Mifepristone 5mg/day by mouth for 6 months
• Inert Capsule
sugar pill

Locations

Country	Name	City	State
United States	University of Rochester School of Medicine & Dentistry	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uterine Volume	Uterine volume is measured in mLs	6 months