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Hormone Therapy

Testosterone Therapy for Low Testosterone and Diabetes

Phase 4
Recruiting
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
Male veterans only
35 to 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Study 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.Check my eligibility
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.See study design
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 a male veteran.
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I am between 35 and 65 years old.
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I have type 2 diabetes.
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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 am between 35 and 65 years old.
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I have had diabetes for 15 years or less.

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

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

Side effects data

From 2012 Phase 4 trial • 22 Patients • NCT01208038
19%
Skin irritation
10%
Increased facial hair
5%
per vagina spotting
5%
Acne
5%
Blepharitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Testosterone

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
1,600 Previous Clinical Trials
3,304,957 Total Patients Enrolled
Reina C. Villareal, MDPrincipal InvestigatorMichael E. DeBakey VA Medical Center, Houston, TX

Media Library

Type 2 Diabetes Clinical Trial 2023: Testosterone gel 1.62% Highlights & Side Effects. Trial Name: NCT03887936 — Phase 4

Frequently Asked Questions

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

How many individuals have enrolled in this experiment?

"Yes, clinicaltrials.gov hosts data affirming that this medical research is currently enrolling participants. The trial was initially published on October 1st 2019 and has been recently edited in November 8th 2022. 166 patients are needed to be accepted from a single clinic site."

Answered by AI

Who is eligible to register for this medical experiment?

"This medical trial is seeking 166 volunteers between the ages of 35 and 65 who are diagnosed with type 2 diabetes mellitus. In addition to this, they must possess a plethora of other characteristics including: male gender, 15 years or less duration since diagnosis, A1C below 10.5%, and body mass index (BMI) under 35 kg/m2."

Answered by AI

Are there any open slots still available for participants in this trial?

"According to the data hosted on clinicaltrials.gov, this study is presently enrolling participants and was initially publicised on October 1st 2019 before being revised most recently on November 8th 2022."

Answered by AI

Are there any precedents for utilizing Testosterone gel 1.62% in clinical research?

"Currently, 29 clinical trials are underway for Testosterone gel 1.62%. Of those research studies, 5 have reached the Phase 3 stage of development. Whilst most locations running this trial are in Houston Texas, there is a total of 124 sites across America actively contributing to these experiments."

Answered by AI

Has the FDA approved Testosterone gel 1.62% for use?

"There is extensive research and clinical data pointing to the safety of Testosterone gel 1.62%, thus it was assigned a rating of 3 on our team's scale."

Answered by AI

Does this trial include elderly individuals above the age of eighty-five?

"This clinical trial mandates that prospective participants must be between 35 and 65-years-old, as indicated in the study's inclusion criteria."

Answered by AI

What is the typical purpose of Testosterone gel 1.62%?

"Hypogonadotropic hypogonadism can be managed with an application of Testosterone gel 1.62%. In addition, this treatment is also beneficial for women who have gone through menopause within the last 5 years, as well as those dealing with orchidectomy and orchitis."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Louisiana
Texas
How old are they?
18 - 65
65+
What site did they apply to?
Michael E. DeBakey VA Medical Center, Houston, TX
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
1

What questions have other patients asked about this trial?

What does it do?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

want to try something new. Trying to find a way to keep from gaining more weight due to being hypoglycemic.
PatientReceived no prior treatments
I’m taking 2 different medications for the diabetes and my insurance doesn’t cover testosterone.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Average response time
  • < 1 Day
Most responsive sites:
  1. Michael E. DeBakey VA Medical Center, Houston, TX: < 24 hours
~20 spots leftby Sep 2024