Mifepristone to Treat Uterine Fibroids

Uterine Fibroids Clinical Trial

Official title:

Treatment of Uterine Myoma With 2.5 or 5 mg Mifepristone Daily During 3 Months With 9 Months Post-treatment Follow-up. Randomized Clinical Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01786226
• Other study ID #: Fibroma2.5normal
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: February 5, 2013
• Last updated: September 4, 2014
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: September 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

Objectives: to evaluate the efficacy, safety and quality of life by using 2.5 and mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9 months follow-up period.

The hypothesis of the study is that the 2.5 mg dosage resulted in a lesser reduction in fibroid size but a similar improvement in quality of life when compared to the 5 mg dose.

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: Terminated
• Enrollment: 220
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• 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: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• Oral administration of mifepristone 2.5 mg daily for three months
Experimental: 1
• Oral administration of mifepristone 5 mg daily for three months
Experimental: 2

Locations

Country	Name	City	State
Cuba	Hospital Eusebio Hernández	Ciudad Habana	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Mediterranea Medica S. L.

Country where clinical trial is conducted

Cuba, 

References & Publications (1)

Carbonell JL, Acosta R, Pérez Y, Garcés R, Sánchez C, Tomasi G. Treatment of Uterine Myoma with 2.5 or 5 mg Mifepristone Daily during 3 Months with 9 Months Posttreatment Followup: Randomized Clinical Trial. ISRN Obstet Gynecol. 2013 Jul 29;2013:649030. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of the uterine leiomyomata with 2,5mg vs 5 mg daily of mifepristone after 3 months of treatment	Evaluate efficacy were the percentage changes in fibroid volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination	3 months	Yes
Secondary	Volume of the uterus with 2,5 mg vs 5 md daily of mifepristone after 3 months of treatment.	Evaluate efficacy were the percentage changes in uterus volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination	3 months	Yes

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