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Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg

NCT01257425 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2019-02-08

Study results available
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Summary

The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve \[AUC1-85day\] for serum testosterone in patients with advanced prostate cancer.

Conditions

Interventions

DRUG

Triptorelin Pamoate (Pamorelin® LA 11.25 mg)

Pamorelin® LA 11.25 mg administered as standard IM injection (= reference group) at Day 1 and Day 85. Triptorelin Pamoate (Pamorelin® LA 11.25 mg) applied subcutaneously (s.c.) at Day 1 and Day 85.

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-02-29
Completion
2012-05-31

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

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 NCT01257425 on ClinicalTrials.gov