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Short-term Testosterone Replacement in Testicular Cancer Survivors

NCT03339635 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-07-30

No results posted yet for this study

Summary

To assess the effects of testosterone replacement therapy on fat mass and other components of the metabolic syndrome. A randomized double-blind placebo controlled intervention study, followed by an open-label treatment phase. Results of this pilot study will be used to design a multicenter randomized controlled study in a large group of TC survivors

Conditions

  • Testicular Cancer

Interventions

DRUG

Androgel (Testosterone gel)

Patients will be randomized to treatment with transdermal testosterone gel (Androgel) once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants.

DRUG

Placebo gel

Patients will be randomized to treatment with transdermal placebo gel once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants.

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Janine Nuver, MD, PhD · University Medical Center Groningen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-21
Primary Completion
2024-06-26
Completion
2024-06-26

Countries

  • Netherlands

Study Locations

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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 NCT03339635 on ClinicalTrials.gov