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.


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


METHODS
Two tertiary medical centers in Israel.


METHODS
Thirty-three enrolled women, ages 30-53 years, diagnosed with symptomatic uterine fibroids.


METHODS
Patients received 10 mg mifepristone vaginally daily for 3 months.


METHODS
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.


RESULTS
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.


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


BACKGROUND
NCT00881140.
Departments of Obstetrics and Gynecology, Chaim Sheba Medical Center, Tel-Hashomer, Israel; Affiliated to Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Gil M
GM
Yerushalmi
Departments of Obstetrics and Gynecology, Chaim Sheba Medical Center, Tel-Hashomer, Israel; Affiliated to Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Yinon
Y
Gilboa
Departments of Obstetrics and Gynecology, Chaim Sheba Medical Center, Tel-Hashomer, Israel; Affiliated to Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Ariella
A
Jakobson-Setton
Uterine Fibroid Center, Helen Schneider Hospital for Women, Rabin Medical Center, Pethah-Tikva, Israel; Affiliated to Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Yona
Y
Tadir
Uterine Fibroid Center, Helen Schneider Hospital for Women, Rabin Medical Center, Pethah-Tikva, Israel; Affiliated to Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Chen
C
Goldchmit
Pharmacy Division, Kupat Cholim Leumit, Tel Aviv, Israel.
Danny
D
Katz
Departments of Obstetrics and Gynecology, Chaim Sheba Medical Center, Tel-Hashomer, Israel; Affiliated to Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: dseidman@tau.ac.il.
Daniel S
DS
Seidman
D000282:Administration, Intravaginal; D000328:Adult; D005260:Female; D006727:Hormone Antagonists / Q000008:administration & dosage; D006801:Humans; D007557:Israel / Q000453:epidemiology; D007889:Leiomyoma / Q000175:diagnosis* / Q000188:drug therapy* / Q000453:epidemiology; D008875:Middle Aged; D015735:Mifepristone / Q000008:administration & dosage*; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014594:Uterine Neoplasms / Q000175:diagnosis* / Q000188:drug therapy* / Q000453:epidemiology
D006727:Hormone Antagonists; D015735:Mifepristone
Mifepristone; antiprogestins; fibroid; leiomyoma