Testosterone gel for Healthy Subjects (HS)

Phase-Based Estimates
1
Effectiveness
1
Safety
the University of Western Ontario, London, Canada
Testosterone gel - Drug
Eligibility
18 - 65
Male
Eligible conditions
Healthy Subjects (HS)

Study Summary

Testosterone and Neurovascular Control in Humans

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Testosterone gel will improve 3 primary outcomes, 1 secondary outcome, and 1 other outcome in patients with Healthy Subjects (HS). Measurement will happen over the course of After 7 days GnRH antagonist alone and 7 days GnRH antagonist + Testosterone.

Day 7
Endothelial function
Forearm blood flow
Muscle sympathetic nerve activity
Sex hormones
Skeletal muscle microvascular blood flow

Trial Safety

Trial Design

2 Treatment Groups

No Control Group
GnRH antagonist alone

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Testosterone Gel is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

GnRH antagonist alone
Drug
Intervention: Cetrorelix acetate (Cetrotide)
GnRH antagonist + Testosterone add-backIntervention: Cetrorelix acetate (Cetrotide) + Testosterone gel (Androgel)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testosterone
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: after 7 days gnrh antagonist alone and 7 days gnrh antagonist + testosterone
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly after 7 days gnrh antagonist alone and 7 days gnrh antagonist + testosterone for reporting.

Who is running the study

Principal Investigator
K. S.
Kevin Shoemaker, Principal Investigator
Western University, Canada

Closest Location

the University of Western Ontario - London, Canada

Eligibility Criteria

This trial is for male patients between 18 and 65 years old. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Moderately active
Free of chronic disease

Patient Q&A Section

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

How many people get healthy subjects (hs) a year in the United States?

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Almost 16.9 million US persons are labeled healthy subjects by their primary care providers. hs and the US population have similar risks for prevalent disease.

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What causes healthy subjects (hs)?

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BMI, BMI percentiles, serum IGF-I, serum IGF-I percentiles, serum estradiol, serum estradiol percentiles, serum FSH and SHBG levels, and total testosterone levels are significantly related to obesity and the IGF system. As the proportionality of obesity and the IGF system increase, hs risk of developing certain cancers increases. Higher BMI and SHBG levels are related to cancer in hs and could be used to identify high-risk obese and SHBG deficient hs.

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What are the signs of healthy subjects (hs)?

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The main signs of Hs are fatigue, dyspnea, chest pain, dyspnea, nausea and diarrhea. A minority of Hs report excessive fatigue (16%), dyspnea (5%), chest pain (12%) and nausea (25%).

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What are common treatments for healthy subjects (hs)?

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Most common treatment for Hs is psychostimulant medication. Other common approaches include cognitive-behavioural therapy; a combination of psychodynamic therapy and cognitive behavioural therapy; cognitive-behavioural therapy; and counselling. Finally, the main approaches used are psychotherapy and counselling. Both psychodynamic and cognitive-behavioural approaches are frequently used as well.

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Can healthy subjects (hs) be cured?

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hs who are infected with N. alata in a first attack of disease have not been shown to be more susceptible or to be more severely affected than are hs infected as a result of a second attack of infection. This is probably because N. alata infection may cause a prolonged period of increased susceptibility to recurrence, as well as enhancing the severity of a single attack of N. alata.

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What is healthy subjects (hs)?

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Healthy subjects (hs) are persons who join medical research trials (mesh, hs) or enroll in clinical trials to find alternatives or to test new technologies in clinical research. Healthy subjects do not have symptoms of illness and are not in urgent need of new technology or alternative therapies. Their eligibility requirements are as following: age older than 18, must be medically fit, must not be treated for any mental disorder or addiction, must not be pregnant and not have a history of such, must not have undergone any drug treatment during the previous 3-month prior to enrollment in the trial, and must also not be suffering from an infectious viral or viral disease. Healthy people, like healthy subjects, can be found on [Power](http://www.

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What are the latest developments in testosterone gel for therapeutic use?

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There are several recent therapeutic testosterone gel options from which men can choose for their needs. The selection will mostly depend on what they need to do. If a man is trying to get off the medication that he is being given, or if he may want to start testosterone gel therapy, then the new low molecular weight testosterone gel is going to help. If a man has a strong need to build up muscle mass during testosterone therapy, then the testosterone gel with a low molecular weight has great advantages on that, but if a man wants the stronger and more powerful effect more powerful testosterone can have by injection, then that could be more appropriate. There are also many different testosterone gel products that are formulated to meet various needs.

Unverified Answer

What is testosterone gel?

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[Testosterone gel] is effective for the treatment of male pattern hair loss and is well accepted by young men, [suggesting] it could be a treatment option for older men who have been reluctant to take a hair regrowth product.

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Is testosterone gel typically used in combination with any other treatments?

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Data from a recent study of this study suggest that most testosterone gels in Italy are used with other medication and not as a monotherapy.

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What is the latest research for healthy subjects (hs)?

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For several years, clinical trials on HES and/or placebo-controlled studies have been conducting in various locations all over Europe and the USA. There are many aspects that are being investigated to gain more information about these clinical trials. Currently, there is no consensus to agree how we should run clinical trials in this area and to which extent it is appropriate to do placebo-controlled study.

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What are the common side effects of testosterone gel?

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Side effects of treatment with testosterone gel may be very similar to those occurring with testosterone injected. The most common side effects (occurring in more than 10% of patients) with testosterone, as a result of therapy with testosterone gel, were: insomnia, headache, increased appetite, and weight gain. Other less common, severe, side effects with testosterone gel were increased appetite and body hair growth. The most common side effect with testosterone gel is acne (occurring in 15% of patients). Other side effects (occurring in less than 10% of patients) with testosterone gel include: acne, increased hair growth, breast enlargement, hot flashes and flushing, and increased vaginal hair (in women).

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