Status:
COMPLETED
Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
HRA Pharma
Conditions:
Leiomyoma
Eligibility:
FEMALE
25-50 years
Phase:
PHASE2
Brief Summary
This study will evaluate whether the experimental drug ulipristal acetate can shrink uterine fibroids in pre-menopausal women.
Detailed Description
Uterine leiomyomata (fibroids) are a common benign tumor of the uterine muscle in pre-menopausal women that may cause bleeding, pelvic pain and pressure. Because fibroids grow in the presence of estro...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00290251
Start Date
February 1 2006
End Date
August 1 2010
Last Update
July 15 2024
Active Locations (2)
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1
NIH Clinical Center
Bethesda, Maryland, United States, 20891
2
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892