Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Seattle Institute for Biomedical and Clinical Research
Study ID
NCT04049331
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Fatigue Syndrome, Chronic
  • Hypogonadism, Male

Eligibility Criteria

Sex
MALE
Age
18 Years - 54 Years
Healthy Volunteers
Not accepted

Interventions

  • Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED] — DRUG
    first two doses four weeks apart; following three more doses every ten weeks.
  • placebo — OTHER
    first two doses four weeks apart; following three more doses every ten weeks.

Study Details

The overall goal of this study is to evaluate the effect of a testosterone drug called Depo-Testosterone (or 'testosterone cypionate'), an FDA-approved drug for improving fatigue, sexual function, quality of life, body composition, muscle strength, and physical activity in young cancer survivors who report fatigue and have low testosterone. Main hypothesis is that Testosterone administration in young male cancer survivors who are in remission for at least 1 year, report cancer-related fatigue and have symptomatic testosterone deficiency will be associated with greater improvements in fatigue scores compared with placebo.

Key Dates

Start date
Mar 22, 2021
Status verified
Apr 2026
Primary completion
Jan 30, 2027
Completion
Jan 30, 2027

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Testosterone
    Testosterone undecanoate injection 750 MG/3 ML
  • Placebo Comparator: Placebo
    clinical grade saline 0.9% sodium chloride injection

Primary Outcome Measure

Fatigue change [ Time Frame: 9 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Milena Braga, MD
[email protected]
617-525-9144
Shehzad Basaria, MD (PRINCIPAL_INVESTIGATOR)
Veterans Affairs Puget Sound Health Care SystemSeattleWashington98108
Gary Miranda, LPN
[email protected]
2062776143
Lindsey Anderson, PhD
[email protected]
2062776719
Jose M Garcia, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Brigham and Women's Hospital· Boston, MAVeterans Affairs Puget Sound Health Care System· Seattle, WA

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