Efficacy Study of Vaginal Mifepristone to Treat Uterine Fibroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00881140
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : December 19, 2012
Information provided by (Responsible Party):
BioPro Medical Ltd

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.

Condition or disease Intervention/treatment Phase
Uterine Fibroid Vaginal Bleeding. Drug: mifepristone vaginal tablets Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Vaginal Mifepristone on Reduction of Uterine Fibroids Size and the Symptoms Associated With the Fibroids - Pilot Study (Phase IIa)
Study Start Date : April 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: antiprogestin
Daily use of 10 mg administrated per vagina
Drug: mifepristone vaginal tablets
Daily use of 10 mg administrated per vagina for 3 months
Other Name: mifepristone

Primary Outcome Measures :
  1. Decrease of uterine fibroids volume by 25% and up. [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 53 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00881140

Rabin Medical Center
''Petah Tikva, Hasaron, Israel
Gynecolaoy department - Shiba Medical Center Tel Hashomer
Ramat Gan, Israel, 52621
Sponsors and Collaborators
BioPro Medical Ltd
Principal Investigator: Daniel Seidman, Prof' unaffiliation

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: BioPro Medical Ltd Identifier: NCT00881140     History of Changes
Other Study ID Numbers: bp001
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: December 19, 2012
Last Verified: December 2012

Keywords provided by BioPro Medical Ltd:
oral mifepristone
vaginal tablets

Additional relevant MeSH terms:
Uterine Hemorrhage
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Diseases
Genital Diseases, Female
Pathologic Processes
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents