Mifepristone for Treatment of Uterine Fibroids - Full Text View

Sponsored by:	Mediterranea Medica S. L.
Information provided by:	Mediterranea Medica S. L.
ClinicalTrials.gov Identifier:	NCT00712595

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 II Phase III

Drug Information available for: Mifepristone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Mifepristone 5 mg Versus 10 mg for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.

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:	100
Study Start Date:	January 2007
Study Completion Date:	February 2008
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Mifepristone 10 mg daily for three months	Drug: Mifepristone Oral administration of Mifepristone 10 mg daily for three months
2: Experimental 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, Ciudad Habana
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

Responsible Party:	Mediterranea Medica S. L. ( Dr. Josep Lluis Carbonell i Esteve )
Study ID Numbers:	Mife_Fibroids_01
Study First Received:	July 8, 2008
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00712595
Health Authority:	Cuba: Scientific and Ethics Committee

Keywords provided by Mediterranea Medica S. L.:

Uterine fibroids
mifepristone
antiprogestins

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue
Myofibroma
Connective Tissue Diseases
Mifepristone
Leiomyoma

Additional relevant MeSH terms:

Abortifacient Agents, Steroidal
Neoplasms, Muscle Tissue
Contraceptives, Postcoital, Synthetic
Neoplasms by Histologic Type
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female

Reproductive Control Agents
Luteolytic Agents
Contraceptives, Postcoital
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Abortifacient Agents
Menstruation-Inducing Agents
Contraceptives, Oral, Synthetic
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on January 14, 2009