Clinical trial · Interventional
The Effect of Mifepristone on Uterine Fibroids and Breast Tissue
The Effect of Preoperative Treatment With Mifepristone on Uterine Fibroids and Breast Tissue
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mifegyne | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: placebo
- type
- ACTIVE_COMPARATOR
- label
- I
- description
- Mifepristone (Mifegyne) 50 mg every other day for 3 months
- interventionNames
- Drug: Mifegyne
Primary outcomes (1)
- measure
- Myoma size
- timeFrame
- 2004 to 2007
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- DERIVEDBerger 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. PMID 29890128
- DERIVEDEngman 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. PMID 24324590
- DERIVEDEngman 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. PMID 19389793
- DERIVEDEngman 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. PMID 18579510