Clinical trial NCT00579475: The Effect of Mifepristone on Uterine Fibroids and Breast Tissue
Official title: The Effect of Preoperative Treatment With Mifepristone on Uterine Fibroids and Breast Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Uterine Fibroids
Keywords: mifepristone
leiomyomas
breast epithelial cell proliferation
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2007-12-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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 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

Primary outcomes:
measure: Myoma size
timeFrame: 2004 to 2007
Secondary outcomes:
measure: Breast epithelial cell proliferation
timeFrame: 2004 to 2007
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Dept of Obstetrics and Gynecology, Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Kristina Gemzell Danielsson, Prof.MD.PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berger C, Boggavarapu N, Norlin E, Queckborner S, Hornaeus K, Falk A, Engman M, Ramstrom M, Lalitkumar PGL, Gemzell-Danielsson K. Molecular characterization of PRM-associated endometrial changes, PAEC, following mifepristone treatment. Contraception. 2018 Oct;98(4):317-322. doi: 10.1016/j.contraception.2018.05.020. Epub 2018 Jun 8.
citation: Engman M, Varghese S, Lagerstedt Robinson K, Malmgren H, Hammarsjo A, Bystrom B, Lalitkumar PG, Gemzell-Danielsson K. GSTM1 gene expression correlates to leiomyoma volume regression in response to mifepristone treatment. PLoS One. 2013 Dec 4;8(12):e80114. doi: 10.1371/journal.pone.0080114. eCollection 2013.
citation: Engman M, Granberg S, Williams AR, Meng CX, Lalitkumar PG, Gemzell-Danielsson K. Mifepristone for treatment of uterine leiomyoma. A prospective randomized placebo controlled trial. Hum Reprod. 2009 Aug;24(8):1870-9. doi: 10.1093/humrep/dep100. Epub 2009 Apr 23.
citation: Engman M, Skoog L, Soderqvist G, Gemzell-Danielsson K. The effect of mifepristone on breast cell proliferation in premenopausal women evaluated through fine needle aspiration cytology. Hum Reprod. 2008 Sep;23(9):2072-9. doi: 10.1093/humrep/den228. Epub 2008 Jun 24.