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Effects of Triptorelin When Given Every 6-months Under the Skin to Adult Males With Cancer in the Prostate

NCT05458856 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2025-07-25

Study results available
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Summary

The aim of the study is to determine if triptorelin formulated for use every 6 months (given twice during the study) is effective and safe for when given by injection under the skin for the treatment of adult males with cancer in the prostate.

Conditions

Interventions

DRUG

Triptorelin embonate 22.5 mg

A prolonged release formulation of triptorelin pamoate 22.5 mg 6-month formulation in D, L-lactide-co-glycolide polymers for single subcutaneous injection on Day 1 and Day 169

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-30
Primary Completion
2024-07-08
Completion
2024-07-08
FDA Drug
Yes

Countries

  • Belgium
  • Czechia
  • France
  • Germany
  • Lithuania
  • Netherlands
  • Spain

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 NCT05458856 on ClinicalTrials.gov