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Mifepristone for Treatment of Uterine Fibroids (Mifemyo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00712595
Recruitment Status : Completed
First Posted : July 10, 2008
Last Update Posted : April 23, 2009
Information provided by:
Mediterranea Medica S. L.

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.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Drug: Mifepristone Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Mifepristone 5 mg Versus 10 mg for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.
Study Start Date : January 2007
Actual Primary Completion Date : January 2007
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 Measures :
  1. Volume of the uterus with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00712595

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Hospital Eusebio Hernández
Havana, Ciudad Habana, Cuba, 11400
Sponsors and Collaborators
Mediterranea Medica S. L.
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Principal Investigator: Josep LL. Carbonell, MD Mediterranea Medica
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Responsible Party: Dr. Josep Lluis Carbonell i Esteve, Mediterranea Medica S. L. Identifier: NCT00712595    
Other Study ID Numbers: Mife_Fibroids_01
First Posted: July 10, 2008    Key Record Dates
Last Update Posted: April 23, 2009
Last Verified: April 2009
Keywords provided by Mediterranea Medica S. L.:
Uterine fibroids
Additional relevant MeSH terms:
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Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents