Androgen Replacement Therapy
Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED] for Testicular Hypogonadism
Veterans Affairs Puget Sound Health Care System, Seattle, WA
Targeting 2 different conditionsTestosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED] +1 morePhase 2RecruitingLed by Jose M Garcia, MD, PhDResearch Sponsored by Seattle Institute for Biomedical and Clinical ResearchEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: 18-50 years
Ability and willingness to provide informed consent.
Must not have
Be younger than 18 years old
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up9 months
Awards & highlights
All Individual Drugs Already Approved
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.
Eligible Conditions
- Testicular Hypogonadism
- Chronic Fatigue Syndrome
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You must be between 18 and 50 years old.
Select...
You understand the study and agree to participate in it.
Select...
You had cancer and received chemotherapy or radiation treatment. You have been cancer-free for at least one year.
Select...
You have a type of cancer that is not treated with hormones, such as many solid tumors, lymphomas, and leukemias.
Select...
You have low levels of testosterone in your blood, which can be measured using a specific method. If your total testosterone is less than 348 ng/dl or your free testosterone is less than 70 pg/ml, you may be considered testosterone deficient even if your total testosterone is slightly higher than the normal range.
Select...
You feel tired a lot and have a low score on a test that measures how fatigued you are compared to other people who have had cancer.
Select...
You had cancer before and received chemotherapy and/or radiation treatment. You have been cancer-free for at least one year.
Select...
Have you taken any medicine that increases your appetite in the last 6 months? Answer "yes" if you haven't.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
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 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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 site
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 Investigator
VA Puget Sound Health Care System2 Previous Clinical Trials
68 Total Patients Enrolled
Media Library
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.
Patient
How responsive is this trial?
Typically responds via
Email
Phone Call
Most responsive sites:
- Veterans Affairs Puget Sound Health Care System: < 24 hours
- Brigham and Women's Hospital: < 48 hours
Average response time
- < 2 Days