The Effect of Mifepristone on Uterine Fibroids and Breast Tissue

Uterine Fibroids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00579475
• Other study ID #: WMB300
• Secondary ID: MPA Dnr151:2003/
• Status: Completed
• Phase: Phase 1
• First received: December 21, 2007
• Last updated: May 22, 2015
• Start date: November 2004
• Est. completion date: June 2007

Study information

• Verified date: December 2007
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• Mifegyne
tablets, 50 mg every other day
• placebo

Locations

Country	Name	City	State
Sweden	Dept of Obstetrics and Gynecology, Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myoma size		2004 to 2007	No
Secondary	Breast epithelial cell proliferation		2004 to 2007	No