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Androgen Replacement Therapy

Testosterone Replacement for Fatigue in Male Cancer Survivors

Phase 2
Recruiting
Led By Jose M Garcia, MD, PhD
Research Sponsored by Seattle Institute for Biomedical and Clinical Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cancer survivors who have received chemotherapy and/or radiation therapy for their cancer and are now in remission for at least one year
Non-hormone-dependent cancer, including most solid tumors, lymphomas and leukemias
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

Study Summary

This trial will evaluate the effect of testosterone on fatigue, sexual function, quality of life, body composition, muscle strength, and physical activity in young cancer survivors.

Who is the study for?
This trial is for male cancer survivors aged 18-50 who are in remission for at least a year, experiencing fatigue, and have low testosterone levels. They must be able to consent and not have hormone-dependent cancers. Men with total testosterone below 348 ng/dL or free testosterone under 70 pg/mL may join if they haven't used appetite stimulants in the last six months.Check my eligibility
What is being tested?
The study tests whether Depo-Testosterone (testosterone cypionate) can improve fatigue, sexual function, life quality, body composition, muscle strength, and physical activity compared to a placebo in young male cancer survivors with low testosterone.See study design
What are the potential side effects?
Possible side effects of Depo-Testosterone include acne, changes in sex drive or performance, hair loss or growth on the face/body/hands/feet; headache; gum irritation/pain/redness/swelling/tenderness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a cancer survivor who has been in remission for at least one year after receiving chemotherapy and/or radiation.
Select...
My cancer is not driven by hormones.
Select...
I am between 18 and 50 years old.
Select...
My testosterone levels are lower than normal for a young man.
Select...
I often feel very tired and my fatigue is severe based on a specific test score.
Select...
You understand the study and agree to participate in it.
Select...
I am a cancer survivor in remission for at least one year after treatment.
Select...
I haven't used appetite stimulants in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fatigue change
Secondary outcome measures
Body composition change
Changes to mood and well-being
Daily physical activity change
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TestosteroneExperimental Treatment1 Intervention
Testosterone undecanoate injection 750 MG/3 ML
Group II: PlaceboPlacebo Group1 Intervention
clinical grade saline 0.9% sodium chloride injection

Find a Location

Who is running the clinical trial?

Seattle Institute for Biomedical and Clinical ResearchLead Sponsor
52 Previous Clinical Trials
13,160 Total Patients Enrolled
1 Trials studying Testicular Hypogonadism
230 Patients Enrolled for Testicular Hypogonadism
Jose M Garcia, MD, PhDPrincipal InvestigatorVA Puget Sound Health Care System
2 Previous Clinical Trials
75 Total Patients Enrolled

Media Library

Testosterone Undecanoate (Androgen Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04049331 — Phase 2
Testicular Hypogonadism Research Study Groups: Testosterone, Placebo
Testicular Hypogonadism Clinical Trial 2023: Testosterone Undecanoate Highlights & Side Effects. Trial Name: NCT04049331 — Phase 2
Testosterone Undecanoate (Androgen Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04049331 — Phase 2
Testicular Hypogonadism Patient Testimony for trial: Trial Name: NCT04049331 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please elaborate on the potential side effects of Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED]?

"While there is some data backing the safety of Testosterone Undecanoate, this medication has yet to be proven effective and thus receives a score of 2."

Answered by AI

Are we recruiting participants for this trial at this time?

"Yes, this is an active recruitment as indicated by the most recent update on 8/11/2022. The listing was first posted by the sponsor on 3/22/2021."

Answered by AI

How many participants are involved in this experiment?

"Yes, this is an active trial that is currently recruiting patients. The primary recruitment sites are in New york and Miami. To date, 240 individuals have signed up for the study."

Answered by AI

Are there other ongoing trials with Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED]?

"Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED] was first studied in 2019 at Brigham and Women's Hospital. Since then, there have been 2721 completed studies. Currently, 8 active trials are underway, a majority of which are taking place in Seattle, Washington."

Answered by AI

Can elderly citizens participate in this research?

"Eligible participants for this clinical trial must be between 18 and 54 years old. In contrast, there are 14 other clinical trials that focus on children and 205 that focus on adults over the age of 65."

Answered by AI

Who else is applying?

What state do they live in?
Washington
Texas
Other
Florida
How old are they?
< 18
65+
18 - 65
What site did they apply to?
Veterans Affairs Puget Sound Health Care System
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2
0
3+

What questions have other patients asked about this trial?

Why did patients apply to this trial?

My hormones are out of balance. Especially testosterone. Likely far more and far worse as i suspect these include androgen, estrogen, cortisol, thyroid and *** hormone binding globulin.
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Veterans Affairs Puget Sound Health Care System: < 24 hours
  2. Brigham and Women's Hospital: < 48 hours
Typically responds via
Email
Phone Call
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone
2021. "Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04049331.
All > Mens Health > Chronic Fatigue Syndrome
~87 spots leftby Jan 2026
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