Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine fibroids in pre-menopausal women.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Collaborator: HRA Pharma
• Treatments: Progesterone; Ulipristal acetate

Criteria

INCLUSION CRITERIA:

• Female gender-to evaluate effects in the target population for clinical trials.

• History of uterine leiomyoma causing symptoms of bleeding, pressure, or pain, as defined by the American College of Obstetrics and Gynecology (ACOG) practice bulletin:

• Excessive uterine bleeding will be evidenced by either of the following-profuse bleeding with flooding or clots or repetitive periods lasting for more than 8 days; or anemia due to acute or chronic blood loss;

OR

• Pelvic discomfort caused by leiomyomata, either acute and severe or chronic lower abdominal or low back pressure or bladder pressure with urinary frequency not due to urinary tract infection.

• Uterine leiomyoma(ta) of at least 2 cm size.

• In good health. Chronic medication use is acceptable except for glucocorticoid use. Other chronic medication use may be acceptable at the discretion of the research team. Interval use of over-the-counter drugs is acceptable but must be recorded.

• Menstrual cycles of 24 - 35 days.

• Hemoglobin greater than 10 g/dL (for those wishing surgery); iron may be administered to improve red blood cell counts.

• Willing and able to comply with study requirements.

• Age 25 to 50.

• Using mechanical (condoms, diaphragms) sterilization or abstinence methods of contraception for the duration of the study.

• Negative urine pregnancy test.

• Body mass index (BMI) less than or equal to 33, if a surgical candidate or less than or equal to 35, if not a surgical candidate.

• Creatinine less than 1.3 mg/dL.

• Liver function tests within 130% of upper limit.

• If interested in hysterectomy, no desire for fertility.

EXCLUSION CRITERIA:

• Significant abnormalities in the history, physical or laboratory examination.

• Pregnancy.

• Lactation.

• Use of oral, injectable or inhaled glucocorticoids or megestrol within the last year.

• Unexplained vaginal bleeding.

• History of malignancy within the past 5 years.

• Use of estrogen or progesterone-containing compounds, such as oral contraceptives and hormone replacement therapy, within 8 weeks of study entry, including transdermal, injectable, vaginal and oral preparations.

• Use of agents known to induce hepatic P450 enzymes; use of imidazoles.

• Current use of Gonadotropin-releasing hormone (GnRH) analogs or other compounds that affect menstrual cyclicity.

• Follicle stimulating hormone (FSH) greater than 20 IU/mL.

• Untreated cervical dysplasia.

• Need for interval use of narcotics.

• Abnormal adnexal/ovarian mass.

• Use of herbal medication having estrogenic or antiestrogenic effects within the past 3 months.

• Contradiction to anesthesia, for women planning surgery.

• Genetic causes of leiomyomata.

• Previous participation in the study.

• Known recent rapid growth of fibroids, defined as a doubling in size in six months.