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Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer

NCT01656161 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-09-15

Study results available
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Summary

The primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered by the subcutaneous (under the skin) route in:

* achieving castrate levels of testosterone (\< 1.735 nmol/L) on Day 29 \[i.e., 28 days after investigational medicinal product (IMP) injection\], and
* in maintaining serum testosterone castrate levels from Month 2 (Day 57) to end of Month 12 (Day 337) in participants with advanced prostate cancer.

Conditions

Interventions

DRUG

Triptorelin embonate 22.5 mg

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Debiopharm International SA

    lead INDUSTRY

Principal Investigators

  • Eija Lundstrom, MD · Debiopharm SA

  • J. Bahlmann, MD · Private Practitioner

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01656161 on ClinicalTrials.gov