Efficacy Study of Vaginal Mifepristone to Treat Uterine Fibroids

The Effect of Vaginal Mifepristone on Reduction of Uterine Fibroids Size and the Symptoms Associated With the Fibroids - Pilot Study (Phase IIa)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00881140

Enrollment

Registered

2009-04-15

Start date

2009-04-30

Completion date

2012-07-31

Last updated

2012-12-19

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

Conditions

Uterine Fibroid, Vaginal Bleeding.

Keywords

oral mifepristone, vaginal tablets

Brief summary

The purpose of this study is to evaluate the effect of daily dosage of vaginally mifepristone on reduction of uterine fibroids size and the symptoms associated with uterine fibroids.

Detailed description

Uterine fibroids are benign tumors of the uterus made up of smooth muscle and the extracellular matrix proteins Collagen and Elastin. They are exceptionally common; the cumulative incidence of a diagnosis of fibroids in women aged 25 to 45 is approximately 30 percent. Uterine fibroids can cause abnormal uterine bleeding, dysmenorrhea, lower back pain and non-cyclic pelvic pain. They also can contribute to symptoms related to an enlarging pelvic mass (e.g., urinary frequency or constipation). Uterine fibroids are also associated with an increased risk of complications of pregnancy, and with infertility, although it is unclear whether this association is causative. Symptoms associated with uterine fibroids can have a significant impact on quality of life, with scores on standard measures that are comparable to those for other major chronic diseases

Interventions

DRUGmifepristone vaginal tablets

Daily use of 10 mg administrated per vagina for 3 months

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 53 Years

Healthy volunteers

Inclusion criteria

* Uninterested in fertility during the study. * Premenopausal status. * Active symptoms related to uterine fibroids. * Subjects will be obligated to use non hormonal contraceptives during the study.

Exclusion criteria

* Abnormal liver and renal function * Participants with significant increase in uterine fibroids size during a short time. * Exclusionary health problems contraindicating mifepristone included adrenal disease; sickle cell anemia; severe liver, respiratory, or renal disease; and blood clotting defect. * Current use of steroids, anticoagulants, herbals, or botanicals with possible hormonal effects.

Design outcomes

Primary

Measure	Time frame
Decrease of uterine fibroids volume by 25% and up.	1 year

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026