Efficacy Study of Vaginal Mifepristone to Treat Uterine Fibroids - Full Text View

Sponsors and Collaborators:	BioPro Medical Ltd Data Analysis - Medistat
Information provided by:	BioPro Medical Ltd
ClinicalTrials.gov Identifier:	NCT00881140

Purpose

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.

Condition	Intervention	Phase
Uterine Fibroid Vaginal Bleeding.	Drug: mifepristone vaginal tablets	Phase II

Drug Information available for: Mifepristone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Effect of Vaginal Mifepristone on Reduction of Uterine Fibroids Size and the Symptoms Associated With the Fibroids - Pilot Study (Phase IIa)

Further study details as provided by BioPro Medical Ltd:

Primary Outcome Measures:

Decrease of uterine fibroids volume by 25% and up. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	April 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
antiprogestin: Experimental Daily use of 10 mg administrated per vagina	Drug: mifepristone vaginal tablets Daily use of 10 mg administrated per vagina for 3 months

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

Eligibility

Ages Eligible for Study:	30 Years to 53 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881140

Contacts

Contact: shlomit cohen, mrs

972-54-3009570

shlomitc@lapidot.com

Locations

Israel
Gynecolaoy department - Shiba Medical Center Tel Hashomer	Recruiting
Ramat Gan, Israel, 52621
Contact: Aviva Alagem, nurse Aviva.Alagem@sheba.health.gov.il
Sub-Investigator: Ronit Machtinger, dr'
Sub-Investigator: Yaron Rabinovitz, dr'
Principal Investigator: Daniel Seidman, prof'
Sub-Investigator: Shlomi Cohen, dr'
Sub-Investigator: Dalia Admon, dr'
Sub-Investigator: Yinon Gilboa, dr'

Sponsors and Collaborators

BioPro Medical Ltd

Data Analysis - Medistat

Investigators

Principal Investigator:

Daniel Seidman, Prof'

unaffiliation

More Information

Publications:

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.

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.

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.

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.

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.

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.

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.

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.

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.

Responsible Party:	Lapidot group ( Dr. Tamar Lifshitz )
Study ID Numbers:	bp001, 5300/08
Study First Received:	April 14, 2009
Last Updated:	April 26, 2009
ClinicalTrials.gov Identifier:	NCT00881140 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by BioPro Medical Ltd:

oral mifepristone
vaginal tablets

Study placed in the following topic categories:

Myofibroma
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Mifepristone

Hemorrhage
Contraceptives, Postcoital
Leiomyoma
Hormones
Neoplasms, Connective and Soft Tissue
Connective Tissue Diseases

Additional relevant MeSH terms:

Neoplasms, Muscle Tissue
Contraceptives, Postcoital, Synthetic
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Leiomyoma
Neoplasms, Connective and Soft Tissue
Therapeutic Uses
Menstruation-Inducing Agents

Abortifacient Agents
Connective Tissue Diseases
Contraceptives, Oral, Synthetic
Abortifacient Agents, Steroidal
Myofibroma
Neoplasms by Histologic Type
Mifepristone
Contraceptives, Postcoital
Luteolytic Agents
Pharmacologic Actions
Neoplasms
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on May 07, 2009