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AndroGel Cost vs. Alternatives: A Clinical Comparison of TRT Options

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At a glance

  • Lower cost as reason for route / 35% of injection users, 21% of gel users, 19% of pellet users [1]
  • Satisfaction by route / gels 68%, injections 73%, pellets 70% [1]
  • Mean hematocrit rise vs placebo / intramuscular enanthate or cypionate +4.0%, gel +3.0%, patch +1.4% [2]
  • Hematocrit above 50% in one 3-year review / 66.7% injections, 35.1% pellets, 12.8% gels [5]
  • Boxed warning on the generic testosterone gel 1% label / secondary exposure and virilization in children [6]
  • Blood pressure / increased class-wide with all testosterone products [7]

Why men pick one route over another

In that survey, from one academic urology clinic, injections were chosen by 53% of the 382 men, gels by 31% and pellets by 17% [1]. Lower cost was the reason injections were favored, cited by 35% of injection users versus 21% of gel users and 19% of pellet users [1]. Satisfaction was similar across routes: 68% with gels, 73% with injections and 70% with pellets [1]. Those are stated preferences, not price comparisons.

Hematocrit rises with gels and injections alike

A network meta-analysis of 29 placebo-controlled randomized trials in 3,393 men found every formulation raised mean hematocrit versus placebo: intramuscular enanthate or cypionate by 4.0%, oral testosterone undecanoate by 4.3%, gel by 3.0%, intramuscular undecanoate by 1.6% and patch by 1.4% [2]. Intramuscular enanthate or cypionate raised hematocrit significantly more than patch; the other comparisons, including gel versus injection, were not significantly different [2]. A retrospective review of 178 men followed 3 years found hematocrit above 50% in 66.7% of those on injections, 35.1% on pellets and 12.8% on gels, though the injection group was younger with higher baseline hematocrit and the study was not randomized [5].

Blood pressure rises with every formulation

FDA says ambulatory monitoring confirmed a blood pressure increase with all testosterone products, class-wide [7]. The generic testosterone gel 1% label reports that ambulatory monitoring showed mean systolic and diastolic pressure up 1.9/1.3 mm Hg from baseline after 16 weeks, and 3.0/2.2 mm Hg in patients with hypertension on antihypertensive therapy; the label says the gel is not recommended in patients with uncontrolled hypertension [6]. Oral testosterone undecanoate was associated with a mean systolic rise of 3 to 5 mm Hg [8].

The risk specific to gels

The generic testosterone gel 1% label carries a boxed warning on secondary exposure: virilization has been reported in children secondarily exposed to testosterone gel [6]. Signs reported include enlargement of the penis or clitoris, pubic hair, increased erections and libido, aggressive behavior and advanced bone age; most regressed once exposure stopped, but in a few cases genital enlargement did not fully return to age-appropriate size [6]. The label says children and women should avoid contact with unwashed or unclothed application sites in men using the gel [6].

AndroGel 1.62% is a different product from testosterone gel 1%

AndroGel 1.62% was the gel tested in TRAVERSE [3][4]. The generic testosterone gel 1% label states that its dosing differs from the 1.62% gel, and that topical testosterone products may have different doses, strengths or application instructions that may result in different systemic exposure [6].

Frequently asked questions

Do gels and injections raise hematocrit differently?
In a network meta-analysis of 29 randomized trials, intramuscular enanthate or cypionate raised mean hematocrit 4.0% and gel 3.0% versus placebo, and that comparison was not statistically significant [2]. A 3-year review of 178 men found hematocrit above 50% in 12.8% of gel users versus 66.7% of injection users, but the injection group was younger with higher baseline hematocrit and the study was not randomized [5].
What does the gel boxed warning cover?
The generic testosterone gel 1% label's boxed warning covers virilization reported in children secondarily exposed to testosterone gel, and says children should avoid contact with unwashed or unclothed application sites [6]. Elsewhere the label says children and women should avoid those sites [6].
Does any formulation avoid the blood pressure effect?
FDA says ambulatory monitoring confirmed blood pressure increases with all testosterone products class-wide [7]. The generic gel 1% label reports a mean 1.9/1.3 mm Hg rise from baseline after 16 weeks of ambulatory monitoring [6], and oral testosterone undecanoate was associated with a 3 to 5 mm Hg systolic rise [8].
Is AndroGel 1.62% the same as testosterone gel 1%?
The generic 1% label states that its dosing differs from the 1.62% gel and that topical testosterone products may have different doses, strengths or application instructions that may result in different systemic exposure [6]. AndroGel 1.62% was the gel tested in TRAVERSE [3][4].

References

  1. Kovac JR, Rajanahally S, Smith RP, Coward RM, Lamb DJ, Lipshultz LI. Patient satisfaction with testosterone replacement therapies: the reasons behind the choices. J Sex Med. 2014;11(2):553-62. Patient satisfaction with testosterone replacement therapies: the reasons behind the choices
  2. Nackeeran S, Kohn T, Gonzalez D, White J, Ory J, Ramasamy R. The Effect of Route of Testosterone on Changes in Hematocrit: A Systematic Review and Bayesian Network Meta-Analysis of Randomized Trials. J Urol. 2022;207(1):44-51. The Effect of Route of Testosterone on Changes in Hematocrit: A Systematic Review and Bayesian Network Meta-Analysis of Randomized Trials
  3. Testosterone Information | FDA. Testosterone Information | FDA
  4. Lincoff AM, Bhasin S, Flevaris P, Mitchell LM, Basaria S, Boden WE, et al. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023;389(2):107-117. Cardiovascular Safety of Testosterone-Replacement Therapy
  5. Pastuszak AW, Gomez LP, Scovell JM, Khera M, Lamb DJ, Lipshultz LI. Comparison of the Effects of Testosterone Gels, Injections, and Pellets on Serum Hormones, Erythrocytosis, Lipids, and Prostate-Specific Antigen. Sex Med. 2015;3(3):165-73. Comparison of the Effects of Testosterone Gels, Injections, and Pellets on Serum Hormones, Erythrocytosis, Lipids, and Prostate-Specific Antigen
  6. U.S. National Library of Medicine, DailyMed. Testosterone gel 1% topical (generic, Actavis Pharma for Teva) prescribing information. Testosterone gel 1% topical (generic, Actavis Pharma for Teva) label
  7. FDA issues class-wide labeling changes for testosterone products | FDA. FDA issues class-wide labeling changes for testosterone products | FDA
  8. Swerdloff RS, Wang C, White WB, Kaminetsky J, Gittelman MC, Longstreth JA, et al. A New Oral Testosterone Undecanoate Formulation Restores Testosterone to Normal Concentrations in Hypogonadal Men. J Clin Endocrinol Metab. 2020;105(8):2515-31. A New Oral Testosterone Undecanoate Formulation Restores Testosterone to Normal Concentrations in Hypogonadal Men
Evidence overview for AndroGel Cost vs. Alternatives: A Clinical Comparison of TRT Options