The Effect of Preoperative Treatment With Mifepristone on Uterine Fibroids and Breast Tissue
18 Years
N/A
Female
Uterine Fibroids
Trial Information
The Effect of Preoperative Treatment With Mifepristone on Uterine Fibroids and Breast Tissue
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
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
Type of Study:
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
Outcome Measure:
Myoma size
Outcome Time Frame:
2004 to 2007
Safety Issue:
No
Principal Investigator
Kristina Gemzell Danielsson, Prof.MD.PHD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Karolinska Institutet
Authority:
Sweden: Medical Products Agency
Study ID:
WMB300
NCT ID:
NCT00579475
Start Date:
November 2004
Completion Date:
June 2007
Related Keywords:
- Uterine Fibroids
- mifepristone
- leiomyomas
- breast epithelial cell proliferation
- Leiomyoma
- Myofibroma
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