NCT00751790

Efficacy and Safety of a Triptorelin 6-month Formulation in Patients With Advanced Prostate Cancer

A Multicenter, Open, Non-comparative, Phase III Study on the Efficacy, Pharmacokinetics and Safety of Two Injections of Triptorelin Embonate 22.5 mg 6-month Formulation in Patients With Advanced Prostate Cancer.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Prostatic Neoplasm

Interventions

Type	Name	Description
DRUG	triptorelin embonate (INN)	Triptorelin embonate 22.5 mg 6 month formulation to be injected every 24 weeks

Timeline

• Start date: 2006-07-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2008-09-12
• Last updated: 2014-07-25
• Results posted: 2012-06-13

Locations

1 site across 1 country: South Africa