Vaginal mifepristone for the treatment of symptomatic uterine leiomyomata: an open-label study.

OBJECTIVE

To evaluate the efficacy and safety of 3 months of vaginal mifepristone treatment on leiomyoma volume and related symptoms.

DESIGN

Prospective, open-label, two tertiary centers, phase II clinical trial.

SETTING

Two tertiary medical centers in Israel.

PATIENT(S): Thirty-three enrolled women, ages 30-53 years, diagnosed with symptomatic uterine fibroids.

INTERVENTION(S): Patients received 10 mg mifepristone vaginally daily for 3 months.

MAIN OUTCOME MEASURE(S): Reduction in uterine leiomyoma volume. Improvement in symptoms related to uterine fibroids was assessed with the use of the "Uterine Fibroid Symptoms Quality of Life Questionnaire" (UFS-QoL). The number of bleeding days, safety, and tolerability were secondary measures.

RESULT(S): Mifepristone treatment significantly reduced leiomyoma volume from 135.3 ± 22.9 cc at enrollment to 101.2 ± 22.4 cc after 3 months of treatment. The UFS-QoL Score significantly decreased from 20.7 ± 0.7 at enrollment to 14.0 ± 0.8 after 3 months of treatment. The number of bleeding days significantly decreased by 3.5 days. Endometrial biopsies showed no evidence of endometrial hyperplasia or cellular atypia. There were no major side effects during the course of the study, and treatment was well tolerated.

CONCLUSION(S): Vaginal mifepristone may offer an effective treatment option for women with symptomatic uterine leiomyoma and can improve the patients' quality of life.

CLINICAL TRIAL REGISTRATION NUMBER: NCT00881140.