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The Effect of Mifepristone on Uterine Fibroids and Breast Tissue

This study has been completed.
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00579475
First received: December 21, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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 Intervention Phase
Uterine Fibroids
 Drug: Mifegyne
Drug: placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Preoperative Treatment With Mifepristone on Uterine Fibroids and Breast Tissue

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Myoma size [ Time Frame: 2004 to 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Breast epithelial cell proliferation [ Time Frame: 2004 to 2007 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: November 2004
Study Completion Date: June 2007
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00579475

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

No publications provided by Karolinska Institutet

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kristina Gemzell Danielsson, Professor, MD,PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00579475     History of Changes
Other Study ID Numbers: WMB300, MPA Dnr151:2003/4444
Study First Received: December 21, 2007
Last Updated: December 21, 2007
Health Authority: Sweden: Medical Products Agency

Keywords provided by Karolinska Institutet:
mifepristone
leiomyomas
breast epithelial cell proliferation

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 May 16, 2013