NCT01786226

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
Last Updated

September 5, 2014

Status Verified

September 1, 2014

Enrollment Period

2 years

First QC Date

February 5, 2013

Last Update Submit

September 4, 2014

Conditions

Uterine Fibroids

Keywords

leiomyoma, fibroid, mifepristone, antiprogestins

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Volume of the uterus with 2,5 mg vs 5 md daily of mifepristone after 3 months of treatment.

    3 months

Study Arms (2)

Mifepristone 2.5 mg daily for three months

EXPERIMENTAL

Experimental: 1

Drug: Oral administration of mifepristone 2.5 mg daily for three months

Mifepristone 5 mg daily for three months

EXPERIMENTAL

Experimental: 2

Drug: Oral administration of mifepristone 5 mg daily for three months

Interventions

Oral administration of mifepristone 2.5 mg daily for three monthsDRUG

Experimental: 1

Also known as: Low doses of antiprogestins to treat uterine fibroids
Mifepristone 2.5 mg daily for three months
Oral administration of mifepristone 5 mg daily for three monthsDRUG

Experimental: 2

Also known as: Low doses of antiprogestins to treat uterine fibroids
Mifepristone 5 mg daily for three months

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Eusebio Hernández

Ciudad Habana, La Habana, 11400, Cuba

Location

Related Publications (1)

  • 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.

    PMID: 23984082RESULT

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 7, 2013

Study Start

March 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

September 5, 2014

Record last verified: 2014-09

Locations

CU(1)