Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Leuprolide- Formulation A · 1 trial · 1 indication
The percentage of subjects with testosterone suppression (\<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (\>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.
The adjusted percentage of subjects with testosterone suppression (\<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. The primary efficacy analysis was adjusted to censor subjects who received an anti-androgen at the last testosterone measurement before use of the anti-androgen. One additional subject was censored because of a laboratory error, at the last measurement before the error. The adjusted 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.
The percentage of subjects with testosterone suppression (\<= 50 ng/dL) from Week 4 to Week 48 was calculated by the Kaplan-Meier method for right-censored observations. Subjects who failed testosterone suppression were considered failures on the first day of a testosterone measurement (\>50 ng/dL). Subjects who prematurely discontinued without escaping and those who were successfully suppressed through Week 48 were censored at their last measured testosterone value (Day 337 to Day 340 at Week 48). The 90% 2-sided confidence interval was calculated from Kaplan-Meier estimates.
| Arm | Type | Description |
|---|---|---|
| Leuprolide acetate - Formulation A | EXPERIMENTAL | Leuprolide acetate 45 mg, 6-month depot |
| Leuprolide acetate - Formulation B | EXPERIMENTAL | Leuprolide acetate, 45 mg, 6-month depot |
| Name | Type | Description |
|---|---|---|
| Leuprolide acetate - Formulation A | DRUG | Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation A, 45 mg 6 month depot, 24 weeks apart. |
| Leuprolide acetate - Formulation B | DRUG | Leuprolide acetate was administered as 2 intramuscular (IM) injections of Formulation B, 45 mg 6 month depot, 24 weeks apart. |
Inclusion Criteria: * Voluntarily sign an IRB-approved informed consent form and any required privacy statement/authorization form. * Pre-trial serum testosterone level \>150 ng/dL. * Histologically-confirmed prostatic adenocarcinoma in Jewett Clinical Stage A2, B, C or D and TNM\* classification c...
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Leuprolide- Formulation A is an investigational therapy being studied for the treatment of prostate cancer. It is in Phase 3 clinical development and has been evaluated in a completed Phase 3 trial in adult male patients with prostate cancer. It is not yet approved for commercial use.
Leuprolide- Formulation A is being developed by Abbott Laboratories, which trades on the New York Stock Exchange under the ticker symbol ABT. Abbott is the sponsor of the clinical program for this formulation.
Leuprolide- Formulation A is in Phase 3 clinical development. One Phase 3 trial has been completed, and there are currently no active trials listed for this formulation. It remains an investigational product and has not been approved by the FDA.
Leuprolide- Formulation A has been studied in one completed Phase 3 trial, NCT00626431, titled "A Study of Leuprolide to Treat Prostate Cancer." The trial enrolled 310 male participants aged 18 years and older in the United States and used a controlled design.
Yes, Leuprolide- Formulation A is also known as Leuprolide acetate - Formulation A. These names refer to the same investigational drug candidate being developed by Abbott Laboratories for prostate cancer.