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Mifepristone to Treat Uterine Fibroids

Primary Purpose

Uterine Fibroids

Status
Terminated
Phase
Phase 2
Locations
Cuba
Study Type
Interventional
Intervention
Oral administration of mifepristone 2.5 mg daily for three months
Oral administration of mifepristone 5 mg daily for three months
Sponsored by
Mediterranea Medica S. L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring leiomyoma, fibroid, mifepristone, antiprogestins

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Eusebio Hernández

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mifepristone 2.5 mg daily for three months

Mifepristone 5 mg daily for three months

Arm Description

Experimental: 1

Experimental: 2

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 5, 2013
Last Updated
September 4, 2014
Sponsor
Mediterranea Medica S. L.
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1. Study Identification

Unique Protocol Identification Number
NCT01786226
Brief Title
Mifepristone to Treat Uterine Fibroids
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mediterranea Medica S. L.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids
Keywords
leiomyoma, fibroid, mifepristone, antiprogestins

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mifepristone 2.5 mg daily for three months
Arm Type
Experimental
Arm Description
Experimental: 1
Arm Title
Mifepristone 5 mg daily for three months
Arm Type
Experimental
Arm Description
Experimental: 2
Intervention Type
Drug
Intervention Name(s)
Oral administration of mifepristone 2.5 mg daily for three months
Other Intervention Name(s)
Low doses of antiprogestins to treat uterine fibroids
Intervention Description
Experimental: 1
Intervention Type
Drug
Intervention Name(s)
Oral administration of mifepristone 5 mg daily for three months
Other Intervention Name(s)
Low doses of antiprogestins to treat uterine fibroids
Intervention Description
Experimental: 2
Primary Outcome Measure Information:
Title
Volume of the uterine leiomyomata with 2,5mg vs 5 mg daily of mifepristone after 3 months of treatment
Description
Evaluate efficacy were the percentage changes in fibroid volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Volume of the uterus with 2,5 mg vs 5 md daily of mifepristone after 3 months of treatment.
Description
Evaluate efficacy were the percentage changes in uterus volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Eusebio Hernández
City
Ciudad Habana
State/Province
Havana
ZIP/Postal Code
11400
Country
Cuba

12. IPD Sharing Statement

Citations:
PubMed Identifier
23984082
Citation
Carbonell JL, Acosta R, Perez Y, Garces R, Sanchez 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. doi: 10.1155/2013/649030. eCollection 2013.
Results Reference
result
Links:
URL
http://www.hindawi.com/journals/isrn/2013/649030/
Description
full article

Learn more about this trial

Mifepristone to Treat Uterine Fibroids

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