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Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Active, Not Recruiting → Recruiting
    • Site details revised at 2 of 2 sites
    v19
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v18
  3. Primary and study completion dates: Jan 30, 2026 to Jan 30, 2027
    • Site contacts updated at 1 of 2 sites
    v17
  4. Re-verified, no change to tracked fieldsv16
  5. Eligibility criteria shortened, about 5 wordsv15
Show 13 earlier versionsHide 13 earlier versions
  1. Site contacts updated at 1 of 2 sitesv14
  2. Primary and study completion dates: Apr 30, 2026 to Jan 30, 2026v13
  3. Eligibility criteria shortened, about 4 wordsv12
  4. Primary and study completion dates: Apr 30, 2025 to Apr 30, 2026v11
  5. Primary and study completion dates: Apr 30, 2024 to Apr 30, 2025v10
  6. Site contacts updated at 2 of 2 sitesv9
  7. Start date: Feb 10, 2020 to Mar 22, 2021
    • Primary completion date: Dec 1, 2024 to Apr 30, 2024
    • Study completion date: Dec 1, 2025 to Apr 30, 2024
    v8
  8. Interventions: Testosterone cypionate 125 mg/week (Drug), placebo (Other) to Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED] (Drug), placebo (Other)
    • Site details revised at 1 of 2 sites
    v7
  9. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    v6
  10. Phase: Phase 4 to Phase 2
    • Start date: Jan 10, 2020 to Feb 10, 2020
    v5
  11. Start date: Dec 1, 2019 to Jan 10, 2020v4
  12. Start date: Sep 1, 2019 to Dec 1, 2019
    • Primary completion date: Sep 1, 2024 to Dec 1, 2024
    • Study completion date: Sep 1, 2025 to Dec 1, 2025
    v3
  13. Secondary endpoints revised (9)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04049331
Lead Sponsor Seattle Institute for Biomedical and Clinical Research
Conditions
(from sponsor)		 Hypogonadism, Male, Fatigue Syndrome, Chronic
Related terms Eunuchism, Fatigue Syndrome, Chronic, Hypogonadism
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov