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Mifepristone 10 or 5 mg for 6 Months to Treat Uterine Fibroids (Mifemyo_2)

Primary Purpose

Uterine Fibroids

Status
Completed
Phase
Phase 2
Locations
Cuba
Study Type
Interventional
Intervention
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 fibroids
  • 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 the side effects of mifepristone
  • Agreeing to have ultrasound examinations in every follow-up or evaluation visit
  • Agreeing in 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 Hernandez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

Oral administration of mifepristone 5 mg daily for six months.

Oral administration of mifepristone 10 mg daily for six months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Prevalence of symptoms after 6 months treatment with 5 or 10 mg of mifepristone.

Full Information

First Posted
April 22, 2009
Last Updated
October 16, 2014
Sponsor
Mediterranea Medica S. L.
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1. Study Identification

Unique Protocol Identification Number
NCT00886873
Brief Title
Mifepristone 10 or 5 mg for 6 Months to Treat Uterine Fibroids
Acronym
Mifemyo_2
Official Title
Mifepristone 5 mg Versus 10 mg During 6 Months for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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 for 6 months of 5 mg versus 10 mg. A 6 month follow-up of subjects is carried out to estimate how the effects of mifepristone are kept in time. The hypothesis of this study is that both mifepristone doses reduce the volume of the myoma up to 50% in six months treatment.
Detailed Description
Women, in fertile age or premenopausal status, presenting symptomatic myomaswere randomly assigned to receive 5 or 10 mg of mifepristone for six months. The decreasing in the prevalence of symptoms attributable to myomas is an important goal to achieve under both treatments. Another goal is to maintain for more than 6 months the benefits of the treatment with mifepristone.

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
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Oral administration of mifepristone 5 mg daily for six months.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Oral administration of mifepristone 10 mg daily for six months.
Intervention Type
Drug
Intervention Name(s)
Mifepristone
Primary Outcome Measure Information:
Title
Volume of the uterine leiomyomata with 5 versus 10 mg of mifepristone daily after six months of treatment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Prevalence of symptoms after 6 months treatment with 5 or 10 mg of mifepristone.
Time Frame
6 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 fibroids 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 the side effects of mifepristone Agreeing to have ultrasound examinations in every follow-up or evaluation visit Agreeing in 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
Carbonell Josep Ll., MD
Organizational Affiliation
Mediterranea Medica S. L.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Eusebio Hernandez
City
Ciudad Habana
State/Province
La Habana
ZIP/Postal Code
13300
Country
Cuba

12. IPD Sharing Statement

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Mifepristone 10 or 5 mg for 6 Months to Treat Uterine Fibroids

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