This study is NOT currently recruiting participants.
Number
06-CH-0090
Sponsoring Institute
National Institute of Child Health and Human Development (NICHD)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Female Min Age: 25 Max Age: 50
Referral Letter Required
Yes
Population Exclusion(s)
Male;Children
Keywords
Fibroid; Leiomyomata
Recruitment Keyword(s)
Uterine Fibroids; Fibroids
Condition(s)
Leiomyomata; Leiomyoma
Investigational Drug(s)
CDB-2914
Investigational Device(s)
None
Intervention(s)
Drug: Ulipristal acetate 10 mg Drug: Placebo Drug: ulipristal acetate
Supporting Site
National Institute of Child Health and Human DevelopmentHRA
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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 megesterol 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 GnRH analogs or other compounds that affect menstrual cyclicity. 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.
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 megesterol 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 GnRH analogs or other compounds that affect menstrual cyclicity.
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.
Principal Investigator
Referral Contact
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