Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin [amount hidden]

What Was Tested

This registered phase 2 trial tested Triptorelin.

It had two arms (groups): one (other) and one (other).

The registry classes the interventions as drug.

Who Took Part

The registry lists 109 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Histologically or cytologically proven prostate cancer, locally advanced or metastatic, or rising PSA (prostate-specific antigen) after failed local therapy, and the patient scheduled to receive androgen deprivation therapy. Karnofsky performance index \> 70. Expected survival ≥ 9 months.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: patient at risk of spinal cord compression or ureter obstruction; prior hypophysectomy or adrenalectomy.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Triptorelin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Triptorelin study: the participants and staff both knew the treatment.

It started in 2010-12 with completion listed for 2012-02.

It ran at 22 sites in Germany (22).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).

It also tracked 6 secondary outcomes, for example Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d), Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d), Maximum Concentration of Serum Testosterone [Cmax] - Raw Data, Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data, Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL and Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Triptorelin in 109 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Triptorelin compound page, all human trials.