Improving Quality of Life of Prostate Cancer Survivors With Androgen Deficiency

NCT03716739 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2025-09-23

No results posted yet for this study

Summary

The purpose of this phase II trial is to determine the efficacy and safety of testosterone replacement therapy (TRT) in improving the symptoms of androgen deficiency and health-related quality of life in men with prostate cancer who have undergone radical prostatectomy.

Conditions

Interventions

DRUG

Testosterone Cypionate 100 MG/ML

100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.

DRUG

Placebo

Placebo administered by intramuscular injection weekly for 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Shalender Bhasin, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2025-05-16
Completion
2025-07-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT03716739 on ClinicalTrials.gov