Testosterone Gel

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Testosterone Gel

Testosterone gel delivers a steady dose of testosterone through daily skin applications. These gels are a relatively convenient and effective method of administering testosterone replacement therapy for men with low testosterone.1-9

Transdermal forms of testosterone are relatively new. They were first introduced in the US in 2000. Most forms are only available under a brand name. As a result, testosterone gels are typically more expensive than injectable testosterone, which is available in generic forms.

Testosterone gels and injectable forms of testosterone are the most commonly prescribed forms for testosterone replacement therapy (TRT). Many prescription gels are available in the United States. These include Androgel, Axiron, Bio-T-Gel, Fortesta, Testim, and Vogelxo.

 


 

Testosterone Gel: Pros and Cons

The need for a transdermal testosterone gel arose to overcome the drawbacks of the other testosterone forms of delivery. For instance, injectable forms are associated with fluctuations (peaks and troughs) of testosterone levels in the period between injections, patches are associated with a high incidence of application site reactions, and pellets are associated with the risk of extrusion. (For more information on general TRT side effects, see EMG’s Side Effects of Testosterone Therapy Article).

Testosterone gels mimic the natural release of testosterone in the body. They do not produce the peaks and troughs in serum testosterone more typical of injectable forms of testosterone because they are applied daily in the morning. This is beneficial because it prevents the typical “yo-yo” effect of fluctuating testosterone levels, which increases the chance of side effects. Also, this form is easy to apply to the stomach, shoulders, upper arms, or inner thighs, and the dosage can be easily adjusted.

Anecdotally, some men complain that testosterone gels do not fully raise testosterone levels back up to normal levels. Experience has shown that some patients may never absorb enough testosterone from gels to improve symptoms.

Pros:

  • Gels provide steadier concentrations of testosterone levels in the blood (gels mimic the physiologic release of testosterone in the body) than other forms of administration. These steadier testosterone levels potentially reduce side effects.
  • Testosterone levels reach a steady-state in the first 24 hours of application and remain in the normal range for the duration of the application.
  • Dosages can be easily modified.
  • Easy application to stomach, shoulders, pectorals, or inner thighs. Different gels have different application sites, so read the product’s specific directions prior to application.
  • Many prescription gels are available in the US.

Cons:

  • Must be applied every day.
  • Can potentially cause adverse skin reactions as well as dark hair growth where the cream is applied.10,11 Adverse skin reactions can usually be avoided by regularly rotating the application site.
  • Testosterone gel can potentially rub off on anyone who comes into contact with you although transfer is typically insignificant once gel dries.
  • Anecdotally, many men complain that these gels do not fully raise testosterone levels back up to normal desired levels.

Suppliers

Many prescription gels are available in the United States. Typical formulations use a hydro-alcoholic gel in 2.5, 5, or 10 gram quantities with 1% active testosterone (10 milligrams of testosterone per gram). These formulations deliver 25, 50, or 100 mg of testosterone per day, respectively. Recently, a generic version became available by prescription (Bio-T-Gel), potentially reducing the cost of TRT, although many insurance companies cover the cost of TRT anyway. Available gels include the following.

  • Androgel® (Abbott Laboratories)
  • Axiron® (Lilly USA LLC)
  • Bio-T-GelTM (Teva Pharmaceuticals)
  • FORTESTA® (Endo Pharmaceuticals)
  • Testim® (Endo Pharmaceuticals)
  • VogelxoTM (Upsher-Smith Laboratories)

 


 

Differences Between Androgel, Axiron, Bio-T-Gel, Fortesta, Testim, and Vogelxo

By and large, the primary differences between the commercially available gels are the application mode and site. Androgel, Axiron, and Fortesta come in a metered-dose pump. Bio-T-Gel comes in a packet. Testim comes in a foil-lined tube. Vogelxo comes in either a metered-dose pump or single-use packets and tubes. Androgel, Testim, and Vogelxo are applied to the shoulders and upper arms. Bio-T-Gel is applied to the shoulders, upper arms and abdomen. Axiron is applied to the underarms with a special applicator that looks similar to a deodorant stick. FORTESTA is applied to the inner thigh.

In all cases, the testosterone gel should be applied at the same time each morning on intact dry skin. Patients are advised to wash their hands well after application. They should also allow the application site to dry for a few minutes and cover the site with clothing.

No studies have been performed that compare the effectiveness or bioavailability of all five gels together. While it is possible that each testosterone gel provides a somewhat different level of absorption, evaluating testosterone levels and adjusting dosages accordingly can easily offset these differences. This is why it is necessary to follow up with a doctor to monitor your testosterone levels.

Read on to learn about the background, application mode, regularity, and site for each brand of testosterone gel.

Androgel

Background: Androgel, the first testosterone gel product, became available as a prescription drug in 2000 in the US. It was developed by Unimed Pharmaceuticals, which was later acquired by Solvay. Abbott later acquired Solvay. In 2011, Abbott introduced a more concentrated formulation called Androgel 1.62%. The more concentrated formulation requires less gel to deliver the same amount of testosterone. This formulation requires less surface area to be spread over. Recently, Abbott separated into two companies: Abbott and Abbvie. Abbvie now sells it.

Androgel Application

Application Mode: Androgel comes in a metered-dose pump or in packets. The gel contains either 1% or 1.62% testosterone. 1.62% is the most recent product formulation. The pump dispenses a preset amount of testosterone gel per pump, which you apply with your hands. Based on your T levels, your doctor will prescribe between one to four pumps daily. Much like the pump, each packet is pre-measured to offer the exact prescribed amount of testosterone for your treatment. Based on your T levels, your doctor will prescribe between one to two packets (between one (20.25 mg) packet and two (40.5 mg) packets for Androgel 1.62%). Androgel Application Information.

Application Regularity: Androgel should be applied once daily at the same time each morning.

Application Site: Androgel is applied to one or both of your shoulders and upper arms. These areas are the areas that are covered by a short-sleeved T-shirt. It should not be applied to any other parts of your body, such as your stomach area (abdomen), penis, or scrotum. Directions indicate to perform three steps after application. 1) Wash your hands with soap and water. 2) Let the application sites dry. 3) Cover the application sites with a short-sleeved T-shirt.

 

Axiron

Background: In 2010, Lily acquired Axiron from the Acrux, an Australian pharmaceutical company. Later that year, Axiron was approved by the FDA and became available as a prescription drug in the US.

Axiron Application

Application Mode: Axiron is available in a metered-dose pump and applied with an applicator cup. The gel contains 2% testosterone. The pump dispenses a preset amount of testosterone gel per pump into an applicator cup. The applicator cup is then used to swipe the underarm. The applicator cup should only hold one pump worth of gel. If your doctor prescribes multiple pumps, perform multiple swipes. Based on your T levels, your physician will prescribe between 1 to 4 pumps. Axiron Application Information.

Application Regularity: Axiron should be applied once daily at the same time each morning.

Application Site: Axiron is applied to one or both of underarms. Application is very similar to applying deodorant. Deodorant should be applied first at least a two minutes prior to applying Axiron. This time allows the deodorant to fully dry before application. It should not be applied to any other parts of your body, such as your stomach area (abdomen), penis, scrotum, shoulders or upper arms. Axiron directions indicate to perform three steps after application. 1) Wash your hands with soap and water. 2) Let the application sites dry. 3) Dress to cover the application sites.

 

Bio-T-Gel

Bio-T-Gel Application

Background: Bio-T-Gel was approved by the FDA in 2012 after being developed by BioSante Pharmaceuticals. It is marketed and sold by Teva Pharmaceuticals.

Application Mode: Bio-T-Gel comes in packets. Each packet is pre-measured to offer the exact prescribed amount of testosterone for your treatment, which you apply with your hands. Based on your T levels, your doctor will prescribe the appropriate number of packets to apply.

Application Regularity: Bio-T-Gel should be applied once daily at the same time each morning.

Application Site: Bio-T-Gel is applied to one or both of your shoulders and upper arms as well as the abdomen. It should not be applied to any other parts of your body, such as your penis or scrotum. Bio-T-Gel directions indicate to perform three steps after application. 1) Wash your hands with soap and water. 2) Let the application sites dry. 3) Cover the application sites with a short-sleeved T-shirt.

 

FORTESTA

Fortesta Application

Background: Endo Pharmaceuticals received FDA approval for FORTESTA in 2010. FORTESTA is still sold by Endo.

Application Mode: FORTESTA comes in a metered-dose pump. The gel contains 2% testosterone. The pump dispenses a preset amount of testosterone gel per pump, which you apply with your fingers. Based on your T levels, your doctor will prescribe the appropriate number of pumps. FORTESTA Application Information.

Application Regularity: FORTESTA should be applied once daily at the same time each morning.

Application Site: FORTESTA is applied to one or both of your front and inner thighs. These areas are the areas that are covered by shorts. It should not be applied to any other parts of your body, such as your stomach area (abdomen), penis, scrotum, shoulders, or upper arms. After use perform the following three steps: 1) Wash your hands with soap and water. 2) Let the application sites dry. 3) Cover the application sites with shorts or pants.

 

Testim

Testim Application

Background: Auxilium Pharmaceuticals received FDA approval for Testim in 2002. Testim is now sold by Endo Pharmaceuticals.

Application Mode: Testim comes in single-use foil-lined tubes. The gel contains 1% testosterone, which you apply with your hands. Based on your T levels, your doctor will prescribe the appropriate number of tubes. Testim Application Information.

Application Regularity: Testim should be applied once daily at the same time each morning.

Application Site: Testim is applied to one or both of your shoulders and upper arms. These areas are the areas that are covered by a short-sleeved T-shirt. It should not be applied to any other parts of your body, such as your stomach area (abdomen), penis, or scrotum. After use perform the following three steps: 1) Wash your hands with soap and water. 2) Let the application sites dry. 3) Cover the application sites with a short-sleeved T-shirt.

 
 

Vogelxo

Vogelxo

Background: Upsher-Smith Laboratories received FDA approval for Vogelxo in 2014. Vogelxo is still sold by Upsher-Smith.

Application Mode: Vogelxo comes in either a metered-dose pump or single-use foil-lined tubes and packets. The gel contains 1% testosterone, which you apply with your hands. Based on your T levels, your doctor will prescribe the appropriate number of pumps from the metered-dose pump or single-use tubes. Vogelxo Application Information.

Application Regularity: Vogelxo should be applied once daily at the same time each morning.

Application Site: Vogelxo is applied to one or both of your shoulders and upper arms. These areas are the areas that are covered by a short-sleeved T-shirt. It should not be applied to any other parts of your body, such as your stomach area (abdomen), penis, or scrotum. After use perform the following three steps: 1) Wash your hands with soap and water. 2) Let the application sites dry. 3) Cover the application sites with a short-sleeved T-shirt.

 
 

For more information on the different available TRT administration methods, select any of the the links below.

EMG’s TRT Resource: Types of Testosterone

External Resources: Medscape: Transdermal Testosterone Gel

Updated: April 25, 2015

 

1. Wang C, Cunningham G, Dobs A, et al. 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.

2. Meikle AW, Matthias D, Hoffman AR. Transdermal testosterone gel: pharmacokinetics, efficacy of dosing and application site in hypogonadal men. BJU Int. Apr 2004; 93 (6): 789-795.

3. Lakshman KM. and Basaria S. Safety and efficacy of testosterone gel in the treatment of male hypogonadism. Clin Interv Aging. 2009; 4: 397–412.

4. Dean JD., Carnegie C., Rodzvilla Jr. J., Smith T. Long-Term Effects of Testim® 1% Testosterone Gel in Hypogonadal Men. Rev Urol. 2005 Spring; 7(2): 87–94.

5. Marbury T, Hamill E, Bachand R, Sebree T, Smith T. Evaluation of the pharmacokinetic profiles of the new testosterone topical gel formulation, Testim, compared to AndroGel. Biopharm Drug Dispos. 2003; 24(3): 115–120.

6. McNicholas TA, Dean JD, Mulder H, Carnegie C, Jones NA. A novel testosterone gel formulation normalizes androgen levels in hypogonadal men, with improvements in body composition and sexual function. BJU Int. 2003; 91(1):69–74.

7. Kuhnert B, Byrne M, Simoni M, et al. Testosterone substitution with a new transdermal, hydroalcoholic gel applied to scrotal or non-scrotal skin: a multicentre trial. Eur J Endocrinol. 2005; 153(2): 317–326.

8. Steidle C, Schwartz S, Jacoby K, Sebree T, Smith T, Bachand R. AA2500 Testosterone gel normalizes androgen levels in aging males with improvements in body composition and sexual function. J Clin Endocrinol Metab. 2003; 88(6): 2673–2681.

9. Mazer N, Bell D, Wu J, Fischer J, Cosgrove M, Eilers B. Comparison of the steady-state pharmacokinetics, metabolism, and variability of a transdermal testosterone patch versus a transdermal testosterone gel in hypogonadal men. J Sex Med. 2005; 2(2): 213–226.

10. Solvay Pharmaceuticals. AndroGel 1% Testosterone Gel US prescribing information. Available at http://www.solvaypharmaceuticals-us.com/static/wma/pdf/1/3/1/4/androgel_prescribing.pdf. Accessed October 12, 2004.

11. Auxilium Pharmaceuticals. Testim 1% Testosterone Gel US prescribing information. Available at http://www.auxilium.com/PrescribingInformation-04Sep2003.pdf. Accessed October 12, 2004.