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
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 administered by intramuscular injection weekly for 12 weeks.
Sponsors & Collaborators
-
National Institute on Aging (NIA)
collaborator NIH - lead OTHER
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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