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

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: NCT00886873
Recruitment Status : Completed
First Posted : April 23, 2009
Last Update Posted : October 17, 2014
Information provided by (Responsible Party):
Dr. Josep Lluis Carbonell i Esteve, Mediterranea Medica S. L.

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Mifepristone 5 mg Versus 10 mg During 6 Months for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.
Study Start Date : May 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Group 1
Oral administration of mifepristone 5 mg daily for six months.
Drug: Mifepristone
Experimental: Group 2
Oral administration of mifepristone 10 mg daily for six months.
Drug: Mifepristone

Primary Outcome Measures :
  1. Volume of the uterine leiomyomata with 5 versus 10 mg of mifepristone daily after six months of treatment [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Prevalence of symptoms after 6 months treatment with 5 or 10 mg of mifepristone. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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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 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

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): NCT00886873

Hospital Eusebio Hernandez
Ciudad Habana, La Habana, Cuba, 13300
Sponsors and Collaborators
Mediterranea Medica S. L.
Principal Investigator: Carbonell Josep Ll., MD Mediterranea Medica S. L.

Responsible Party: Dr. Josep Lluis Carbonell i Esteve, Medical Director, Mediterranea Medica S. L. Identifier: NCT00886873     History of Changes
Other Study ID Numbers: Mife_Fibroids_02
First Posted: April 23, 2009    Key Record Dates
Last Update Posted: October 17, 2014
Last Verified: October 2014

Keywords provided by Dr. Josep Lluis Carbonell i Esteve, Mediterranea Medica S. L.:
Uterine fibroids

Additional relevant MeSH terms:
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