The Effect of Mifepristone on Uterine Fibroids and Breast Tissue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00579475
Recruitment Status : Completed
First Posted : December 24, 2007
Last Update Posted : May 25, 2015
Information provided by:
Karolinska Institutet

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Uterine Fibroids Drug: Mifegyne Drug: placebo Phase 1

Detailed Description:

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Preoperative Treatment With Mifepristone on Uterine Fibroids and Breast Tissue
Study Start Date : November 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: placebo
Active Comparator: I
Mifepristone (Mifegyne) 50 mg every other day for 3 months
Drug: Mifegyne
tablets, 50 mg every other day

Primary Outcome Measures :
  1. Myoma size [ Time Frame: 2004 to 2007 ]

Secondary Outcome Measures :
  1. Breast epithelial cell proliferation [ Time Frame: 2004 to 2007 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00579475

Dept of Obstetrics and Gynecology, Karolinska University Hospital
Stockholm, Sweden, SE17176
Sponsors and Collaborators
Karolinska Institutet
Principal Investigator: Kristina Gemzell Danielsson, Prof.MD.PHD Karolinska Institutet

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kristina Gemzell Danielsson, Professor, MD,PhD, Karolinska Institutet Identifier: NCT00579475     History of Changes
Other Study ID Numbers: WMB300
MPA Dnr151:2003/4444
First Posted: December 24, 2007    Key Record Dates
Last Update Posted: May 25, 2015
Last Verified: December 2007

Keywords provided by Karolinska Institutet:
breast epithelial cell proliferation

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