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Testosterone Therapy for Low Testosterone and Diabetes
Study Summary
This trial will test if testosterone can improve the bone health of male veterans who have both low testosterone and diabetes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 4 trial • 22 Patients • NCT01208038Trial Design
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Who is running the clinical trial?
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- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Michael E. DeBakey VA Medical Center, Houston, TX: < 24 hours
Average response time
- < 1 Day
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