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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02147197 | A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas | PHASE3 | COMPLETED | 157 | — | — | Mar 31, 2014 | Mar 29, 2016 | Apr 30, 2019 | 28 | United States |
| NCT02147158 | A Study of the Efficacy and Safety of Ulipristal Acetate Intermittent Treatment for Abnormal Uterine Bleeding Associated With Leiomyomas | PHASE3 | COMPLETED | 432 | — | — | Jan 29, 2014 | Nov 24, 2016 | Jun 4, 2019 | 63 | United States, Canada |
Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e. no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in the 12-week Treatment Period.
Time to absence of bleeding was defined as the duration in days from first dose to the first day in the time interval in which absence of bleeding occurs and persists through the last dose on treatment. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose on treatment in the 12-week Treatment Period.
Participants recorded bleeding in a daily diary. Absence of bleeding was defined as no bleeding days (i.e., no entries for bleeding or heavy bleeding; however, spotting was allowed), during the last 35 consecutive days on treatment in Treatment Course 1.
Time to absence of bleeding was defined as the duration in days from first dose to the first day in the time interval in which absence of bleeding occurs and persists through the last dose in the first treatment course. The persistence of absence of bleeding occurred for a minimum of 35 consecutive days counting backward from the last dose in Treatment Course 1.
| Arm | Type | Description |
|---|---|---|
| UPA 5 mg | EXPERIMENTAL | Ulipristal acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks. |
| UPA 10 mg | EXPERIMENTAL | UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks. |
| UPA 5 mg:Placebo | EXPERIMENTAL | Ulipristal Acetate (UPA) 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2. |
| UPA 10 mg:Placebo | EXPERIMENTAL | UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 2. |
| UPA 5 mg:UPA 5 mg | EXPERIMENTAL | UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses. |
| UPA 10 mg:UPA 10 mg | EXPERIMENTAL | UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily in both Treatment Course 1 and Treatment Course 2. There was a 2 menses drug-free interval in between courses. |
| Placebo:UPA 5 mg | EXPERIMENTAL | Matching placebo tablets (5 mg and 10 mg) orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 5 mg tablet plus matching placebo 10 mg tablet, orally, once daily for 12 weeks in Treatment Course 2. |
| Placebo:UPA 10 mg | EXPERIMENTAL | Matching placebo tablets (5 mg and 10 mg), orally, once daily for 12 weeks in Treatment Course 1; followed by a 2 menses drug-free interval; followed by UPA 10 mg tablet plus matching placebo 5 mg tablet, orally, once daily for 12 weeks in Treatment Course 2. |
| Name | Type | Description |
|---|---|---|
| Ulipristal acetate (UPA) | DRUG | UPA tablet |
| Placebo | DRUG | Matching placebo tablet. |
Inclusion Criteria: * Pre-menopausal women, 18-50 years, inclusive. * Cyclic abnormal uterine bleeding (heavy or prolonged). * Menstrual blood loss (MBL) of ≥ 80 mL as measured by the alkaline hematin method in the first 8 days of menses. * Minimum of one discrete leiomyoma observable by transvagin...