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Hormone Therapy

Testosterone Therapy for Low Testosterone and Diabetes

Phase 4
Waitlist Available
Led By Reina C. Villareal, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 35 to 65 years old
35 to 65 years old
Must not have
Prostate-related findings such as a palpable prostate nodule on digital rectal exam (DRE), serum PSA of 4.0 ng/ml, International Prostate Symptom Score (IPSS) >19 (severe), on androgen therapy or selective androgen receptor modulators
Diseases that interfere with bone metabolism such as hyperparathyroidism, untreated hyperthyroidism, osteomalacia, chronic liver disease, renal failure, hypercortisolism, malabsorption, immobilization, current alcohol use of > 3 drinks/day
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will test if testosterone can improve the bone health of male veterans who have both low testosterone and diabetes.

Who is the study for?
This trial is for male veterans aged 35-65 with type 2 diabetes and low testosterone (T levels <300 ng/dl). They should have a BMI under 35, an A1C level below 10.5%, and be experiencing symptoms of hypogonadism. Men with severe prostate issues, certain blood conditions, or those on medications affecting bone metabolism are excluded.
What is being tested?
The study tests if testosterone gel improves bone health in men who have both diabetes and low testosterone. Participants will either receive the testosterone gel or a placebo to compare effects on bone quality over time.
What are the potential side effects?
Potential side effects of testosterone therapy may include skin reactions at the application site, mood swings, increased red blood cell count which can lead to complications like clotting disorders, and possible aggravation of sleep apnea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 35 and 65 years old.
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I am between 35 and 65 years old.
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My diabetes is under control with an A1C below 10.5%.
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I am a male veteran.
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I have type 2 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have prostate issues indicated by a nodule, high PSA, severe symptoms, or I'm on hormone therapy.
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I do not have conditions like thyroid issues or liver disease that affect bone health.
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I have a history of prostate or breast cancer.
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I have had a blood clot, stroke, or heart artery disease.
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I have a history of testicular disease.
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I have severe sleep apnea that hasn't been treated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bone and Bones
Secondary study objectives
Markers of bone turnover to measure bone metabolism
Osteoblast and osteoclast progenitor cells which are cells found in bone

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Testosterone armExperimental Treatment1 Intervention
Testosterone gel 1.62%
Group II: Placebo armPlacebo Group1 Intervention
Matching placebo will be prepared by the Michael DeBakey VA Medical Center Pharmacy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone gel 1.62%
2009
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,696 Total Patients Enrolled
Reina C. Villareal, MDPrincipal InvestigatorMichael E. DeBakey VA Medical Center, Houston, TX

Media Library

Hypergonadotropic Hypogonadism Clinical Trial 2023: Testosterone gel 1.62% Highlights & Side Effects. Trial Name: NCT03887936 — Phase 4
~15 spots leftby Nov 2025
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