Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ulipristal · 3 trials · 3 indications
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. |
| Normal Renal Function | EXPERIMENTAL | Ulipristal acetate, 10 mg, oral administration |
| Moderate Renal Impairment | EXPERIMENTAL | Ulipristal acetate, 10 mg, oral administration |
| Severe Renal Impairment | EXPERIMENTAL | Ulipristal acetate, 10 mg, oral administration |
| Name | Type | Description |
|---|---|---|
| Ulipristal acetate (UPA) | DRUG | UPA tablet |
| Placebo | DRUG | Matching placebo tablet. |
| Ulipristal acetate | DRUG | - |
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...
Ulipristal is a small molecule being developed by AbbVie Inc. for the treatment of abnormal uterine bleeding associated with leiomyomas, which are uterine fibroids. It has also been studied in patients with moderately or severely impaired renal function. The drug is currently in Phase 3 clinical development for these indications.
Ulipristal is a selective progesterone receptor modulator. It works by modulating the activity of progesterone receptors, which are involved in the growth of uterine fibroids. By affecting these receptors, ulipristal can help reduce bleeding associated with leiomyomas.
Ulipristal is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the drug's efficacy and safety in treating abnormal uterine bleeding associated with leiomyomas.
Ulipristal is in Phase 3 clinical development. Two Phase 3 trials have been completed, studying the drug for abnormal uterine bleeding associated with leiomyomas. The drug is investigational and has not been approved by regulatory authorities for any indication.
Ulipristal has been studied in two completed Phase 3 trials: NCT02147158, which enrolled 432 participants, and NCT02147197, which enrolled 157 participants. Both trials evaluated the drug for abnormal uterine bleeding associated with leiomyomas in the United States and Canada.
Ulipristal is the active ingredient in the drug product ulipristal acetate. The clinical trials for this drug use ulipristal acetate as the investigational agent. The drug is being developed by AbbVie Inc. for the treatment of abnormal uterine bleeding associated with leiomyomas.