Trial | NCT00881140  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    mifepristone ...

  • Study Participants

    30
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.
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 Started
Apr 30
2009
Primary Completion
May 31
2012
Study Completion
Jul 31
2012
Last Update
Dec 19
2012
Estimate

Drug mifepristone vaginal tablets

Daily use of 10 mg administrated per vagina for 3 months

  • Other names: mifepristone

antiprogestin Experimental

Daily use of 10 mg administrated per vagina

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.
No Results Posted