Mifepristone for Treatment of Uterine Fibroids

Uterine Fibroids Clinical Trial

— Mifemyo  

Official title:

Mifepristone 5 mg Versus 10 mg for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712595
• Other study ID #: Mife_Fibroids_01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 8, 2008
• Last updated: April 22, 2009
• Start date: January 2007
• Est. completion date: March 2009

Study information

• Verified date: April 2009
• Source: Mediterranea Medica S. L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: Scientific and Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2009
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• Mifepristone
Oral administration of Mifepristone 10 mg daily for three months
• Mifepristone
Oral administration of Mifepristone 5 mg, daily for three months

Locations

Country	Name	City	State
Cuba	Hospital Eusebio Hernández	Havana	Ciudad Habana

Sponsors (1)

Lead Sponsor	Collaborator
Mediterranea Medica S. L.

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of the uterine leiomyomata with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment		3 months	Yes
Secondary	Volume of the uterus with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment		3 months	Yes