Uterine Fibroids Clinical Trial
Official title:
The Effect of Preoperative Treatment With Mifepristone on Uterine Fibroids and Breast Tissue
Verified date | December 2007 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Medical Products Agency |
Study type | Interventional |
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
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Dept of Obstetrics and Gynecology, Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Myoma size | 2004 to 2007 | No | |
Secondary | Breast epithelial cell proliferation | 2004 to 2007 | No |
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