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Mifepristone for Treatment of Uterine Fibroids (Mifemyo)

Primary Purpose

Uterine Fibroids

Status
Completed
Phase
Phase 2
Locations
Cuba
Study Type
Interventional
Intervention
Mifepristone
Mifepristone
Sponsored by
Mediterranea Medica S. L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring Uterine fibroids, mifepristone, antiprogestins

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Symptomatic uterine leiomyomata
  • Reproductive age or premenopausal
  • Accepting the use of non hormonal contraception
  • Conformity in keeping a monthly log of all episodes of vaginal bleeding during the treatment as well as all side effects of mifepristone
  • Agreeing to have ultrasound examinations in every follow-up or evaluation visit
  • Agreeing to two endometrial biopsies: one before starting treatment and another in the following 10 days after treatment termination.

Exclusion Criteria:

  • Pregnancy or desire to become pregnant
  • Breastfeeding
  • Hormonal contraception or any hormonal therapy received in the last three months
  • Signs or symptoms of pelvic inflammatory disease
  • Adnexal masses
  • Abnormal or unexplained vaginal bleeding
  • Suspected or diagnosed malignant neoplastic disease
  • Signs or symptoms of mental illness
  • Adrenal disease
  • Sickle cell anemia
  • Hepatic disease
  • Renal disease
  • Coagulopathy
  • Any other severe or important disease
  • Any contraindication to receiving antiprogestins

Sites / Locations

  • Hospital Eusebio Hernández

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Mifepristone 10 mg daily for three months

Mifepristone 5 mg daily for three months

Outcomes

Primary Outcome Measures

Volume of the uterine leiomyomata with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment

Secondary Outcome Measures

Volume of the uterus with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment

Full Information

First Posted
July 8, 2008
Last Updated
April 22, 2009
Sponsor
Mediterranea Medica S. L.
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1. Study Identification

Unique Protocol Identification Number
NCT00712595
Brief Title
Mifepristone for Treatment of Uterine Fibroids
Acronym
Mifemyo
Official Title
Mifepristone 5 mg Versus 10 mg for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mediterranea Medica S. L.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objectives of this study are to estimate the efficacy and safety of the daily administration of mifepristone 5 mg versus 10 mg for three months for the treatment of uterine fibroids. The hypothesis of the study is that both mifepristone doses reduce the volume of the myoma in about 40% after 3 months of treatment.
Detailed Description
Women, in fertile age or in premenopausal status, presenting symptomatic uterine fibroids were randomly assigned to receive 5 mg or 10 of mifepristone. The diminishing of prevalence of symptoms attributable to uterine fibroids is the most important goal to achieve under both treatments. The possible side effects of mifepristone are slight and women's adherence to treatment is remarkable. Also the reduction of the volumes of the uterus and fibroids contribute to enhance the wellbeing of subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids
Keywords
Uterine fibroids, mifepristone, antiprogestins

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Mifepristone 10 mg daily for three months
Arm Title
2
Arm Type
Experimental
Arm Description
Mifepristone 5 mg daily for three months
Intervention Type
Drug
Intervention Name(s)
Mifepristone
Other Intervention Name(s)
Low doses of antiprogestins to treat uterine fibroids.
Intervention Description
Oral administration of Mifepristone 10 mg daily for three months
Intervention Type
Drug
Intervention Name(s)
Mifepristone
Intervention Description
Oral administration of Mifepristone 5 mg, daily for three months
Primary Outcome Measure Information:
Title
Volume of the uterine leiomyomata with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Volume of the uterus with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptomatic uterine leiomyomata Reproductive age or premenopausal Accepting the use of non hormonal contraception Conformity in keeping a monthly log of all episodes of vaginal bleeding during the treatment as well as all side effects of mifepristone Agreeing to have ultrasound examinations in every follow-up or evaluation visit Agreeing to two endometrial biopsies: one before starting treatment and another in the following 10 days after treatment termination. Exclusion Criteria: Pregnancy or desire to become pregnant Breastfeeding Hormonal contraception or any hormonal therapy received in the last three months Signs or symptoms of pelvic inflammatory disease Adnexal masses Abnormal or unexplained vaginal bleeding Suspected or diagnosed malignant neoplastic disease Signs or symptoms of mental illness Adrenal disease Sickle cell anemia Hepatic disease Renal disease Coagulopathy Any other severe or important disease Any contraindication to receiving antiprogestins
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josep LL. Carbonell, MD
Organizational Affiliation
Mediterranea Medica
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Eusebio Hernández
City
Havana
State/Province
Ciudad Habana
ZIP/Postal Code
11400
Country
Cuba

12. IPD Sharing Statement

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Mifepristone for Treatment of Uterine Fibroids

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