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Mifepristone for Treatment of Uterine Fibroids (Mifemyo)

This study has been completed.
Sponsor:
Information provided by:
Mediterranea Medica S. L.
ClinicalTrials.gov Identifier:
NCT00712595
First received: July 8, 2008
Last updated: April 22, 2009
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Uterine Fibroids
 Drug: Mifepristone
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Mifepristone 5 mg Versus 10 mg for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mediterranea Medica S. L.:

Primary Outcome Measures:
  • Volume of the uterine leiomyomata with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Volume of the uterus with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: January 2007
Study Completion Date: March 2009
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Mifepristone 10 mg daily for three months
 Drug: Mifepristone
Oral administration of Mifepristone 10 mg daily for three months
Other Name: Low doses of antiprogestins to treat uterine fibroids.
Experimental: 2
Mifepristone 5 mg daily for three months
 Drug: Mifepristone
Oral administration of Mifepristone 5 mg, daily for three months

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712595

Locations
Cuba
Hospital Eusebio Hernández
Havana, Ciudad Habana, Cuba, 11400
Sponsors and Collaborators
Mediterranea Medica S. L.
Investigators
Principal Investigator: Josep LL. Carbonell, MD Mediterranea Medica
  More Information

No publications provided

Responsible Party: Dr. Josep Lluis Carbonell i Esteve, Mediterranea Medica S. L.
ClinicalTrials.gov Identifier: NCT00712595     History of Changes
Other Study ID Numbers: Mife_Fibroids_01
Study First Received: July 8, 2008
Last Updated: April 22, 2009
Health Authority: Cuba: Scientific and Ethics Committee

Keywords provided by Mediterranea Medica S. L.:
Uterine fibroids
mifepristone
antiprogestins

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Mifepristone
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
 Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 23, 2013