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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00886873
Other study ID # Mife_Fibroids_02
Secondary ID
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


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
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