NCT00881140

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2009

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 19, 2012

Status Verified

December 1, 2012

Enrollment Period

3.1 years

First QC Date

April 14, 2009

Last Update Submit

December 18, 2012

Conditions

Uterine FibroidVaginal Bleeding.

Keywords

oral mifepristonevaginal tablets

Outcome Measures

Primary Outcomes (1)

  • Decrease of uterine fibroids volume by 25% and up.

    1 year

Study Arms (1)

antiprogestin

EXPERIMENTAL

Daily use of 10 mg administrated per vagina

Drug: mifepristone vaginal tablets

Interventions

mifepristone vaginal tabletsDRUG

Daily use of 10 mg administrated per vagina for 3 months

Also known as: mifepristone
antiprogestin

Eligibility Criteria

Age30 Years - 53 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Abnormal liver and renal function
  • Participants with significant increase in uterine fibroids size during a short time.
  • Current use of steroids, anticoagulants, herbals, or botanicals with possible hormonal effects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rabin Medical Center

Petah Tikva, Hasaron, Israel

Location

Gynecolaoy department - Shiba Medical Center Tel Hashomer

Ramat Gan, 52621, Israel

Location

Related Publications (9)

  • 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. doi: 10.1097/01.AOG.0000243776.23391.7b.

    PMID: 17138770BACKGROUND

  • 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. doi: 10.1097/01.AOG.0000127622.63269.8b.

    PMID: 15172874BACKGROUND

  • 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. doi: 10.1016/s0029-7844(02)02511-5.

    PMID: 12576246BACKGROUND

  • 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. doi: 10.1016/s0029-7844(01)01702-1.

    PMID: 11814511BACKGROUND

  • 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. doi: 10.1016/j.jmig.2005.01.022.

    PMID: 15922980BACKGROUND

  • 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. doi: 10.1210/jcem.76.2.8432797.

    PMID: 8432797BACKGROUND

  • 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.

    PMID: 9275461BACKGROUND

  • 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.

    PMID: 7789557BACKGROUND

  • Yerushalmi GM, Gilboa Y, Jakobson-Setton A, Tadir Y, Goldchmit C, Katz D, Seidman DS. Vaginal mifepristone for the treatment of symptomatic uterine leiomyomata: an open-label study. Fertil Steril. 2014 Feb;101(2):496-500. doi: 10.1016/j.fertnstert.2013.10.015. Epub 2013 Nov 9.

    PMID: 24220703DERIVED

MeSH Terms

Conditions

LeiomyomaUterine Hemorrhage

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Daniel Seidman, Prof'

    unaffiliation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2009

First Posted

April 15, 2009

Study Start

April 1, 2009

Primary Completion

May 1, 2012

Study Completion

July 1, 2012

Last Updated

December 19, 2012

Record last verified: 2012-12

Locations

IL(2)