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

Sponsor

Mediterranea Medica S. L. (Other)

Overall Status

Completed

CT.gov ID

NCT00886873

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 1, 2008

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Volume of the uterine leiomyomata with 5 versus 10 mg of mifepristone daily after six months of treatment [6 months]

Secondary Outcome Measures

Prevalence of symptoms after 6 months treatment with 5 or 10 mg of mifepristone. [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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