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Completed

NCT Number: NCT00579475

The Effect of Mifepristone on Uterine Fibroids and Breast Tissue

Uterine fibroids are a benign but common condition among women in reproductive age. It is one of the most common reasons for hysterectomy since it often causes bleeding problems sometimes leading to anemia. Several alternative treatment regimens have been investigated that could replace surgery. The antiprogesterone, mifepristone, is one of the most promising drugs that have been tested. In addition to the inhibiting effect on the growth of uterine fibroids antiprogestins have been proposed to have an antiproliferative effect on breast tissue.

The purpose of the present study is to evaluate the effect of mifepristone on the volume of uterine fibroids. The study will also address the effect of mifepristone on the breast tissue

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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 and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Dept of Obstetrics and Gynecology, Karolinska University Hospital

Stockholm, SE17176, Sweden

About this study

Other purposes of this study include:

  • To develop a new non-surgical method for treatment of uterine fibroids
  • To study the effect of mifepristone on the size of uterine fibroids
  • To evaluate factors regulating fibroid growth by comparison with untreated fibroids and normal myometrium
  • To study the effect of mifepristone on the amount of blood loss and pelvic pain in patients with fibroids
  • To study the effect of mifepristone on proliferation of breast tissue

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Uterine fibroids requiring treatment

  • Good general health
  • Willing and able to participate after giving informed consent

Exclusion criteria

  • Need for immediate surgery
  • Concomitant hormonal treatment (HRT)
  • History of malignant disorder of the breast
  • Any contraindication for mifepristone

Criteria for retrospective exclusion:

Subjects may be excluded from analysis if one of the following applies:

  • Any violation of the study protocol
  • Lack of essential data

Treatment and study plan

Mifegyne

Drug

tablets, 50 mg every other day

Placebo

Drug

Primary outcomes

  1. Myoma size

    Time frame: 2004 to 2007

Secondary outcomes

  1. Breast epithelial cell proliferation

    Time frame: 2004 to 2007

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

The Effect of Preoperative Treatment With Mifepristone on Uterine Fibroids and Breast Tissue

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Dec 24, 2007
Registry last updated
May 25, 2015

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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