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Trial of Mifepristone for Fibroids

Primary Purpose

Leiomyoma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Mifepristone
Inert Capsule
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leiomyoma focused on measuring A benign tumor derived from smooth uterine muscle tissue.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Rochester School of Medicine & Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mifepristone

Inert capsule

Arm Description

Mifepristone 5 MG capsule taken once daily by mouth

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

Outcomes

Primary Outcome Measures

Uterine Volume
Uterine volume is measured in mLs

Secondary Outcome Measures

Full Information

First Posted
August 22, 2005
Last Updated
September 5, 2023
Sponsor
University of Rochester
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00133705
Brief Title
Trial of Mifepristone for Fibroids
Official Title
Randomized Control Trial Of Mifepristone for Fibroids
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leiomyoma
Keywords
A benign tumor derived from smooth uterine muscle tissue.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mifepristone
Arm Type
Experimental
Arm Description
Mifepristone 5 MG capsule taken once daily by mouth
Arm Title
Inert capsule
Arm Type
Placebo Comparator
Arm Description
Placebo (for Mifepristone) capsule of nearly identical color, size, and weight taken once daily by mouth
Intervention Type
Drug
Intervention Name(s)
Mifepristone
Other Intervention Name(s)
RU486
Intervention Description
Mifepristone 5mg/day by mouth for 6 months
Intervention Type
Drug
Intervention Name(s)
Inert Capsule
Intervention Description
sugar pill
Primary Outcome Measure Information:
Title
Uterine Volume
Description
Uterine volume is measured in mLs
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Fiscella, MD, MPH
Organizational Affiliation
University of Rochester School of Medicine & Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester School of Medicine & Dentistry
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15922980
Citation
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.
Results Reference
background
PubMed Identifier
12576246
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.
Results Reference
background
PubMed Identifier
17138770
Citation
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.
Results Reference
derived

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Trial of Mifepristone for Fibroids

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