Efficacy Study of Vaginal Mifepristone to Treat Uterine Fibroids

Uterine Fibroid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00881140
• Other study ID #: bp001
• Secondary ID: 5300/08
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2009
• Last updated: December 18, 2012
• Start date: April 2009
• Est. completion date: July 2012

Study information

• Verified date: December 2012
• Source: BioPro Medical Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 53 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroid
• Vaginal Bleeding.

Intervention

Drug:
• mifepristone vaginal tablets
Daily use of 10 mg administrated per vagina for 3 months

Locations

Country	Name	City	State
Israel	Rabin Medical Center	''Petah Tikva	Hasaron
Israel	Gynecolaoy department - Shiba Medical Center Tel Hashomer	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
BioPro Medical Ltd

Country where clinical trial is conducted

Israel, 

References & Publications (8)

Eisinger SH, Bonfiglio T, Fiscella K, Meldrum S, Guzick DS. Twelve-month safety and efficacy of low-dose mifepristone for uterine myomas. J Minim Invasive Gynecol. 2005 May-Jun;12(3):227-33. — View Citation

Eisinger SH, Meldrum S, Fiscella K, le Roux HD, Guzick DS. Low-dose mifepristone for uterine leiomyomata. Obstet Gynecol. 2003 Feb;101(2):243-50. — View Citation

Fiscella K, Eisinger SH, Meldrum S, Feng C, Fisher SG, Guzick DS. Effect of mifepristone for symptomatic leiomyomata on quality of life and uterine size: a randomized controlled trial. Obstet Gynecol. 2006 Dec;108(6):1381-7. — View Citation

Murphy AA, Kettel LM, Morales AJ, Roberts VJ, Yen SS. Regression of uterine leiomyomata in response to the antiprogesterone RU 486. J Clin Endocrinol Metab. 1993 Feb;76(2):513-7. — View Citation

Murphy AA, Morales AJ, Kettel LM, Yen SS. Regression of uterine leiomyomata to the antiprogesterone RU486: dose-response effect. Fertil Steril. 1995 Jul;64(1):187-90. — View Citation

Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002 Feb;99(2):290-300. — View Citation

Steinauer J, Pritts EA, Jackson R, Jacoby AF. Systematic review of mifepristone for the treatment of uterine leiomyomata. Obstet Gynecol. 2004 Jun;103(6):1331-6. Review. — View Citation

Yang Y, Zheng S, Li K. [Treatment of uterine leiomyoma by two different doses of mifepristone]. Zhonghua Fu Chan Ke Za Zhi. 1996 Oct;31(10):624-6. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease of uterine fibroids volume by 25% and up.		1 year	Yes