Androgel

Please note that the hub is for internal use only. If you wish to utilise materials included in the hub externally, then the materials must be subject to local legal, medical and regulatory (LMR) review and approval.

AndroGel 16.2 mg/g gel and AndroGel 1% gel preparations are indicated in adults as testosterone replacement therapies for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.

The brand name ‘Testogel’ is used in some countries. As the AndroGel brand name is more widely used globally, and for brevity, we will use this term throughout (unless otherwise stated).

Evidence & Data Generation

In this section you will find information on the pivotal trials of both Androgel 1% and Androgel 16.2mg/g pump (1.62%). Additionally, you will find extensive information on the TRAVERSE study and the TTrials which represent some of the longest and largest RCTs ever performed with testosterone therapy in hypogonadal men.

You will also find additional resources such as literature updates, slide deck summaries, frequently asked questions, formulary support documents and an objection handler.

In this section you will find monthly literature updates, information related to the pivotal clinical trials of AndroGel 1% and AndroGel 16.2mg/g pump, as well as information on the Testosterone Trials (TTrials), which were a series of 7 co-ordinated clinical trials conducted at 12 US sites to assess the efficacy of the AndroGel (1%) pump preparation for 1 year in older men (>65 years) with hypogonadism. Information for the TRAVERSE Trial designed to evaluate the cardiovascular safety of TRT which due to its large size and long duration, also offered an opportunity to study effects on prostate safety events and several patient-important efficacy endpoints is also included.

The TRAVERSE Trial was designed to evaluate the cardiovascular safety of TRT. Due to its large size and long duration, the trial offered an opportunity to study effects on prostate safety events and several patient-important efficacy endpoints. This section will be added to as publications become available.

A study looking at the effect of AndroGel 16.2 mg/g in addition to intensive lifestyle intervention in older men with obesity, mild-to-moderate frailty and hypogonadism.
Testosterone Replacement Therapy Added to Intensive Lifestyle Intervention in Older Men With Obesity and Hypogonadism. The Journal of Clinical Endocrinology & Metabolism, 2021, Vol. 106, No. 3, e1096–e1110.

The pivotal studies for AndroGel 1% that studied pharmacokinetics, efficacy and safety, as well as quality of life, were published between 2000 and 2012
Long-Term Pharmacokinetics of Transdermal Testosterone Gel in Hypogonadal Men J Clin Endocrinol Metab, 2000 Vol. 85 No. 12
Long-Term Testosterone Gel (AndroGel) Treatment Maintains Beneficial Effects on Sexual Function and Mood, Lean and Fat Mass, and Bone Mineral Density in Hypogonadal Men J Clin Endocrinol Metab, May 2004, 89(5):2085–2098.
A randomized, double-blind, placebo-controlled trial of testosterone gel on body composition and health-related quality-of-life in men with hypogonadal to low-normal levels of serum testosterone and symptoms of androgen deficiency over 6 months with 12 months open-label follow-up The Aging Male, 2012; 15(4): 198–207

The Testosterone Trials (TTrials) were seven co-ordinated trials of AndroGel 1% pump treatment in elderly men (>65 years) that comprised, at the time, the largest randomised, placebo-controlled study on testosterone ever conducted.
Effects of Testosterone Treatment in Older Men N Engl J Med 2016;374:611-24.
The Effects of Testosterone Replacement on Self-reported and Performance-based Measures of Mobility in Older Men with Mobility Limitation and Low Testosterone Levels: A Placebo Controlled Trial. Lancet Diabetes Endocrinol. 2018 November; 6(11): 879–890.
Association of Testosterone Levels with Anaemia in Older Men: A Controlled Clinical Trial JAMA Intern Med. 2017;177(4):480-490.
A corrigendum was submitted to the journal due to an error with some numbers reported in the original manuscript. The errors have been accounted for in the slide deck and video presentation and you can see the details of the corrigendum here.
Testosterone Treatment and Cognitive Function in Older Men with Low Testosterone and Age-Associated Memory Impairment JAMA. 2017;317(7):717-727.
Testosterone Treatment and Coronary Artery Plaque Volume in Older Men with Low Testosterone JAMA. 2017;317(7):708-716.
Effect of Testosterone Treatment on Volumetric Bone Density and Strength in Older Men with Low Testosterone: A Controlled Clinical Trial. JAMA Intern Med. 2017;177(4):471-479.
Lessons from the Testosterone Trials. Endocrine Reviews, June 2018, 39(3):369–386.

The pivotal studies for AndroGel 1% that studied pharmacokinetics, efficacy and safety, as well as quality of life, were published between 2000 and 2012
Long-Term Pharmacokinetics of Transdermal Testosterone Gel in Hypogonadal Men J Clin Endocrinol Metab, 2000 Vol. 85 No. 12
Long-Term Testosterone Gel (AndroGel) Treatment Maintains Beneficial Effects on Sexual Function and Mood, Lean and Fat Mass, and Bone Mineral Density in Hypogonadal Men J Clin Endocrinol Metab, May 2004, 89(5):2085–2098.
A randomized, double-blind, placebo-controlled trial of testosterone gel on body composition and health-related quality-of-life in men with hypogonadal to low-normal levels of serum testosterone and symptoms of androgen deficiency over 6 months with 12 months open-label follow-up The Aging Male, 2012; 15(4): 198–207
The pivotal studies for AndroGel 16.2mg/g pump that studied efficacy and safety were published between 2011 and 2012.
Efficacy and Safety Study of 16.2 mg Testosterone Gel for the Treatment of Hypogonadal Men J Sex Med 2011;8:2079–2089
One-Year Efficacy and Safety Study of a 16.2 mg Testosterone Gel in Hypogonadal Men: Results of a 182-Day Open-Label Extension J Sex Med 2012;9:1149–1161
The Testosterone Trials (TTrials) were seven co-ordinated trials of AndroGel 1% pump treatment in elderly men (>65 years) that comprised, at the time, the largest randomised, placebo-controlled study on testosterone ever conducted.
Effects of Testosterone Treatment in Older Men N Engl J Med 2016;374:611-24.
The Effects of Testosterone Replacement on Self-reported and Performance-based Measures of Mobility in Older Men with Mobility Limitation and Low Testosterone Levels: A Placebo Controlled Trial. Lancet Diabetes Endocrinol. 2018 November; 6(11): 879–890.
Association of Testosterone Levels with Anaemia in Older Men: A Controlled Clinical Trial JAMA Intern Med. 2017;177(4):480-490.
A corrigendum was submitted to the journal due to an error with some numbers reported in the original manuscript. The errors have been accounted for in the slide deck and video presentation and you can see the details of the corrigendum here.
Testosterone Treatment and Cognitive Function in Older Men with Low Testosterone and Age-Associated Memory Impairment JAMA. 2017;317(7):717-727.
Testosterone Treatment and Coronary Artery Plaque Volume in Older Men with Low Testosterone JAMA. 2017;317(7):708-716.
Effect of Testosterone Treatment on Volumetric Bone Density and Strength in Older Men with Low Testosterone: A Controlled Clinical Trial. JAMA Intern Med. 2017;177(4):471-479.
Lessons from the Testosterone Trials. Endocrine Reviews, June 2018, 39(3):369–386.
A recent study looked at the effect of AndroGel 16.2 mg/g in addition to intensive lifestyle intervention in older men with obesity, mild-to-moderate frailty and hypogonadism.
Testosterone Replacement Therapy Added to Intensive Lifestyle Intervention in Older Men With Obesity and Hypogonadism. The Journal of Clinical Endocrinology & Metabolism, 2021, Vol. 106, No. 3, e1096–e1110.
Frequently Asked Questions (FAQs):
Here you can download a document that contains a comprehensive list of frequently asked questions relating to AndroGel that may arise in your communications with healthcare professionals and colleagues.
Supporting Documents for Healthcare Organisations (HCOs):
As is often the case, healthcare organisations will need to review all the relevant clinical data on a pharmaceutical product, along with supportive data from peer-reviewed guideline committees before they make a recommendation on the use of that product. Below you can download examples of such documents that were originally created for the UK market:
Objection Handler
Here you will find an AndroGel objection handler, which is a tool that can assist our customer-facing teams to confidently address commonly encountered healthcare professional objections with relevant, evidence-based responses:

Visit https://portal.besins-healthcare.com/ Home > M&M Platform > Medical > Clinical Operations

Resources

Knowledge transfer of scientific information to new Besins employees and continuous training and upskilling of existing Besins employees is of utmost importance and crucial to our success as an organisation. As a company, we strive to be a valued leader, a trusted partner, and the industry expert in the field of andrology, and to realise these ambitions, we need to ensure that all relevant employees have the required knowledge and expertise.

In this section, you will find many helpful training aids that can be used for onboarding new employees, or for continuing professional development of existing employees. You will also find resources to assist in the education of healthcare professionals and details of relevant scientific congresses in the field of andrology:

Alignment and preparation combined with creative campaigns are key elements for a successful launch. Learn from the experience of teams across Besins.

Here you will find UK launch materials from the UK for both Testogel 16.2mg/g pump (launched in UK in Feb 2018) and Testogel 40.5mg sachet (launched in UK in Feb 2022) which affiliates preparing for the launch may find helpful.

Learn about frequently asked questions (FAQ) for AndroGel with this comprehensive list that may be used in communications with healthcare professionals and colleagues.

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