The Effect of Mifepristone on Uterine Fibroids and Breast Tissue

The Effect of Preoperative Treatment With Mifepristone on Uterine Fibroids and Breast Tissue

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00579475

Enrollment

Registered

2007-12-24

Start date

2004-11-30

Completion date

2007-06-30

Last updated

2015-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Fibroids

Keywords

mifepristone, leiomyomas, breast epithelial cell proliferation

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

Interventions

DRUGMifegyne

tablets, 50 mg every other day

DRUGplacebo

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Myoma size	2004 to 2007

Secondary

Measure	Time frame
Breast epithelial cell proliferation	2004 to 2007

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026