Efficacy Study of Vaginal Mifepristone to Treat Uterine Fibroids

BioPro

Status and phase

Completed

Phase 2

Conditions

Vaginal Bleeding.

Uterine Fibroid

Treatments

Drug: mifepristone vaginal tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT00881140

bp001

5300/08

Details and patient eligibility

About

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.

Full 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

Enrollment

30 patients

Sex

Female

Ages

30 to 53 years old

Volunteers

No Healthy Volunteers

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.