Efficacy Study of Vaginal Mifepristone to Treat Uterine Fibroids

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioPro Medical Ltd
ClinicalTrials.gov Identifier:
NCT00881140
First received: April 14, 2009
Last updated: December 18, 2012
Last verified: December 2012
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


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 ]

Enrollment: 30
Study Start Date: April 2009
Study Completion Date: July 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: BioPro Medical Ltd
ClinicalTrials.gov Identifier: NCT00881140     History of Changes
Other Study ID Numbers: bp001, 5300/08
Study First Received: April 14, 2009
Last Updated: December 18, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by BioPro Medical Ltd:
oral mifepristone
vaginal tablets

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

ClinicalTrials.gov processed this record on July 29, 2014