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

Uterine Fibroids Clinical Trial

— Mifemyo_2  

Official title:

Mifepristone 5 mg Versus 10 mg During 6 Months for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886873
• Other study ID #: Mife_Fibroids_02
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 22, 2009
• Last updated: October 16, 2014
• Start date: May 2008
• Est. completion date: May 2009

Study information

• Verified date: October 2014
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

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

Locations

Country	Name	City	State
Cuba	Hospital Eusebio Hernandez	Ciudad Habana	La 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 versus 10 mg of mifepristone daily after six months of treatment		6 months	Yes
Secondary	Prevalence of symptoms after 6 months treatment with 5 or 10 mg of mifepristone.		6 months	Yes