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Mifepristone to Treat Uterine Fibroids

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Dr. Josep LLuis Carbonell i Esteve, Mediterranea Medica S. L.
ClinicalTrials.gov Identifier:
NCT01786226
First received: February 5, 2013
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Uterine Fibroids
Drug: Oral administration of mifepristone 2.5 mg daily for three months
Drug: Oral administration of mifepristone 5 mg daily for three months
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Mediterranea Medica S. L.:

Primary Outcome Measures:
  • Volume of the uterine leiomyomata with 2,5mg vs 5 mg daily of mifepristone after 3 months of treatment [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Evaluate efficacy were the percentage changes in uterus volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination


Enrollment: 220
Study Start Date: March 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mifepristone 2.5 mg daily for three months
Experimental: 1
Drug: Oral administration of mifepristone 2.5 mg daily for three months
Experimental: 1
Other Name: Low doses of antiprogestins to treat uterine fibroids
Experimental: Mifepristone 5 mg daily for three months
Experimental: 2
Drug: Oral administration of mifepristone 5 mg daily for three months
Experimental: 2
Other Name: Low doses of antiprogestins to treat uterine fibroids

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01786226

Locations
Cuba
Hospital Eusebio Hernández
Ciudad Habana, Havana, Cuba, 11400
Sponsors and Collaborators
Mediterranea Medica S. L.
  More Information

Additional Information:
Publications:
Responsible Party: Dr. Josep LLuis Carbonell i Esteve, Medical Director, Mediterranea Medica S. L.
ClinicalTrials.gov Identifier: NCT01786226     History of Changes
Other Study ID Numbers: Fibroma2.5normal
Study First Received: February 5, 2013
Last Updated: September 4, 2014
Health Authority: Cuba: Scientific and Ethics Committee

Keywords provided by Mediterranea Medica S. L.:
leiomyoma, fibroid, mifepristone, antiprogestins

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Connective Tissue Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Mifepristone
Abortifacient Agents
Abortifacient Agents, Steroidal
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital
Contraceptives, Postcoital, Synthetic
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014