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Completed

NCT Number: NCT00886873

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

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.

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Key information

Conditions

Uterine Fibroids Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Eusebio Hernandez

Ciudad Habana, La Habana, 13300, Cuba

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mifepristone

Drug

Primary outcomes

  1. Volume of the uterine leiomyomata with 5 versus 10 mg of mifepristone daily after six months of treatment

    Time frame: 6 months

Secondary outcomes

  1. Prevalence of symptoms after 6 months treatment with 5 or 10 mg of mifepristone.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Mediterranea Medica S. L.

Other

Registry information

Official study title

Mifepristone 5 mg Versus 10 mg During 6 Months for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.

Acronym: Mifemyo_2

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 23, 2009
Registry last updated
Oct 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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