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| Sponsored by: |
Karolinska Institutet |
|---|---|
| Information provided by: | Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT00579475 |
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 I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | The Effect of Preoperative Treatment With Mifepristone on Uterine Fibroids and Breast Tissue |
| 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: Placebo Comparator | Drug: placebo |
|
I: Active Comparator
Mifepristone (Mifegyne) 50 mg every other day for 3 months
|
Drug: Mifegyne
tablets, 50 mg every other day
|
Other purposes of this study include:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Uterine fibroids requiring treatment
Exclusion Criteria:
Criteria for retrospective exclusion:
Subjects may be excluded from analysis if one of the following applies:
Contacts and Locations| Sweden | |
| Dept of Obstetrics and Gynecology, Karolinska University Hospital | |
| Stockholm, Sweden, SE17176 | |
| Principal Investigator: | Kristina Gemzell Danielsson, Prof.MD.PHD | Karolinska Institutet |
More Information
| Responsible Party: | Karolinska Institutet ( Kristina Gemzell Danielsson, Professor, MD,PhD ) |
| Study ID Numbers: | WMB300, MPA Dnr151:2003/4444 |
| Study First Received: | December 21, 2007 |
| Last Updated: | December 21, 2007 |
| ClinicalTrials.gov Identifier: | NCT00579475 History of Changes |
| Health Authority: | Sweden: Medical Products Agency |
|
mifepristone leiomyomas breast epithelial cell proliferation |
|
Neoplasms, Connective and Soft Tissue Myofibroma Contraceptive Agents Hormone Antagonists Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists |
Contraceptive Agents, Female Connective Tissue Diseases Mifepristone Contraceptives, Postcoital Hormones Leiomyoma |
|
Neoplasms, Muscle Tissue Contraceptives, Postcoital, Synthetic Contraceptive Agents Hormone Antagonists Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Leiomyoma Neoplasms, Connective and Soft Tissue Therapeutic Uses Menstruation-Inducing Agents |
Abortifacient Agents Connective Tissue Diseases Contraceptives, Oral, Synthetic Abortifacient Agents, Steroidal Myofibroma Neoplasms by Histologic Type Mifepristone Contraceptives, Postcoital Luteolytic Agents Pharmacologic Actions Neoplasms Neoplasms, Connective Tissue |
