Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00290251 | Treatment of Uterine Fibroids With the Selective Progesterone Receptor Modulator CDB-2914 | PHASE2 | COMPLETED | 72 | — | — | Feb 1, 2006 | Aug 1, 2010 | Jul 15, 2024 | 2 | United States |
The primary outcome, fibroid volume, was calculated by an ellipsoid formula (π/6xd1xd2xd3) using orthogonal three-dimensional measurements taken from pelvic MRI scan. Individual volumes were summed to assess total fibroid volume for each woman, which were log-transformed before analysis. Women with paired MRI results were included in this intent to treat analysis, even if they did not take all study medication. Fibroids were included if they were seen on both studies.The absolute change in cm3 between baseline and end of treatment was calculated and its log was used for statistics and reporting the results in the data table below.
| Arm | Type | Description |
|---|---|---|
| ulipristal acetate -20 mg | ACTIVE_COMPARATOR | 20 mg daily dose ulipristal acetate for three menstrual cycles or up to 102 days |
| ulipristal acetate - 10 mg | ACTIVE_COMPARATOR | 10 mg daily dose ulipristal acetate for three menstrual cycles or up to 102 days |
| Placebo | PLACEBO_COMPARATOR | Placebo taken daily for three menstrual cycles or up to 102 days |
| Pre-ulipristal acetate 10 mg | NO_INTERVENTION | Subjects were studied during one baseline cycle without any intervention before entering ulipristal acetate 10 mg arm |
| Pre-ulipristal acetate 20 mg | NO_INTERVENTION | Subjects were studied during one baseline cycle without any intervention before entering ulipristal acetate 20 mg arm |
| Pre-placebo | NO_INTERVENTION | Subjects were studied during one baseline cycle without any intervention before entering placebo arm |
| Name | Type | Description |
|---|---|---|
| ulipristal acetate 20 mg | DRUG | ulipristal acetate at a daily dose of 20 mg, given once daily for three menstrual cycles or 90 - 102 days if amenorrheic |
| ulipristal acetate 10 mg | DRUG | 10 mg given daily for three menstrual cycles or 90 - 102 days |
| placebo | DRUG | placebo given once daily for 3 menstrual cycles or 90 - 102 days |
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 bleedin...