Conditions: Prostatic Neoplasm
Keywords: triptorelin, 6-month formulation, advanced prostate cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 120
Healthy volunteers: no

Brief summary:
Efficacy and safety of a triptorelin 6-month formulation in patients with advanced prostate cancer. It was assumed that during the study treatment \>90% of the patients would achieve and maintain castrate levels of serum testosterone.

Detailed description:
Efficacy of triptorelin treatment on gonadotropin (LH) stimulation from hypophysis, as well as on the PSA (prostate specific antigen) levels and safety laboratory parameters. The triptorelin pharmacokinetics and testosterone pharmacodynamics were assessed in a subset of 15 patients.

Arms:
arm 1: None

Interventions: intervention 1: triptorelin embonate (INN)
Intervention descriptions: intervention 1: Triptorelin embonate 22.5 mg 6 month formulation to be injected every 24 weeks

Protocol document: