Mifepristone 10 or 5 mg for 6 Months to Treat Uterine Fibroids (Mifemyo_2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Mediterranea Medica S. L..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mediterranea Medica S. L.
ClinicalTrials.gov Identifier:
NCT00886873
First received: April 22, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Uterine Fibroids
Drug: Mifepristone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Mifepristone 5 mg Versus 10 mg During 6 Months for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded 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 5 versus 10 mg of mifepristone daily after six months of treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Prevalence of symptoms after 6 months treatment with 5 or 10 mg of mifepristone. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: May 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mifepristone 5 mg daily for six months.
Oral administration of mifepristone 5 mg daily.
Drug: Mifepristone
Oral administration of Mifepristone 5 mg daily for three months.
Experimental: Mifepristone 10 mg daily for six months
Oral administration of mifepristone 10 mg daily.
Drug: Mifepristone
Oral administration of Mifepristone 10 mg daily for three months.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00886873

Contacts
Contact: Carbonel Josep Ll., MD +537 260 5911 schja@infomed.sld.cu

Locations
Cuba
Hospital Eusebio Hernandez Recruiting
Ciudad Habana, La Habana, Cuba, 13300
Contact: Acosta Rita, MD    +537 260 5911    schja@infomed.sld.cu   
Sub-Investigator: Perez Yasmiriam, MD         
Sponsors and Collaborators
Mediterranea Medica S. L.
Investigators
Principal Investigator: Carbonell Josep Ll., MD Mediterranea Medica S. L.
  More Information

No publications provided

Responsible Party: Dr. Josep Lluis Carbonell i Esteve, Mediterranea Medica S. L.
ClinicalTrials.gov Identifier: NCT00886873     History of Changes
Other Study ID Numbers: Mife_Fibroids_02
Study First Received: April 22, 2009
Last Updated: April 22, 2009
Health Authority: Cuba: Scientific and Ethics Committee

Keywords provided by Mediterranea Medica S. L.:
Uterine fibroids
Mifepristone
Antiprogestins

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

ClinicalTrials.gov processed this record on July 24, 2014