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AndroGel Year-1 Outcomes: What Real Users Report After 12 Months on Testosterone Gel

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At a glance

  • Drug / Testosterone gel 1.62%; the gel used in TRAVERSE was AndroGel 1.62% [1]
  • TRAVERSE major cardiovascular events / 7.0% gel vs 7.3% placebo, mean treatment 21.7 months [2]
  • Mean hematocrit change, gels vs placebo / +3.0% (95% CI 1.8 to 4.3) [3]
  • Spine trabecular bone density at 1 year / +7.5% vs +0.8% placebo, 211 men [4]
  • Year-one monitoring recommended / symptoms, serum testosterone, hematocrit, prostate cancer risk [5]

Why forum reports differ from measured outcomes

Forum threads and review-site ratings are self-selected comments from people who chose to post, so they cannot show what a typical man experiences at a year. Published data on testosterone gel at 12 months and beyond come from clinical studies that measured specific endpoints.

What did TRAVERSE find in men using AndroGel 1.62%?

TRAVERSE enrolled 5,246 men aged 45 to 80 who had hypogonadism symptoms, two fasting testosterone levels under 300 ng/dL, and existing or high cardiovascular risk. They applied 1.62% testosterone gel daily, dose-adjusted to keep levels between 350 and 750 ng/dL, or placebo gel; mean treatment lasted 21.7 months and mean follow-up 33 months [2]. FDA identifies the gel as AndroGel 1.62%, given to more than 5,200 men [1].

The primary endpoint (cardiovascular death, nonfatal heart attack or nonfatal stroke) occurred in 7.0% of the testosterone group versus 7.3% of placebo, hazard ratio 0.96 (95% CI 0.78 to 1.17), which met noninferiority [2]. FDA reviewed the results and said TRAVERSE did not demonstrate a new safety signal or trend in adverse cardiovascular outcomes [1]. Separately, FDA says required ambulatory blood pressure studies confirmed a blood pressure increase with all testosterone products, class-wide [8].

What changes are measured during the first year?

Hematocrit. Across 29 placebo-controlled randomized trials with 3,393 men, every testosterone formulation raised mean hematocrit versus placebo: gels by 3.0% (95% CI 1.8 to 4.3), intramuscular enanthate or cypionate by 4.0% (2.9 to 5.1), patches by 1.4%, and oral testosterone undecanoate by 4.3% [3]. A review of the literature found erythrocytosis risk is well established with testosterone therapy and that short-acting injectable formulations have the highest incidence [6].

The Endocrine Society's 2018 guideline recommends monitoring symptoms, serum testosterone, hematocrit and prostate cancer risk during the first year of treatment [5].

Bone density after a year

In a separate one-year trial of 211 men aged 65 or older with low testosterone, spine trabecular volumetric bone density rose 7.5% with testosterone gel versus 0.8% with placebo, a treatment effect of 6.8% (95% CI 4.8 to 8.7; P<.001) [4]. That trial measured bone density, not how men said they felt.

Testosterone and fertility

Exogenous testosterone suppresses sperm production, and the Endocrine Society guideline recommends against starting testosterone therapy in men planning fertility in the near term [5]. This is not a gel-specific finding. In a study of 66 men who had become infertile after testosterone use (formulation not specified here), 46 (70%) reached a total motile count above 5 million within 12 months of stopping testosterone and starting high-dose hCG plus a selective estrogen receptor modulator; 64.8% of azoospermic men reached that threshold versus 91.7% of cryptozoospermic men, and older age and longer testosterone use predicted slower recovery [7].

Frequently asked questions

Do forum and Reddit reports show what to expect at a year?
Forum posts are self-selected, so they cannot show typical outcomes. Measured 12-month data come from studies such as TRAVERSE, which used AndroGel 1.62% and reported major cardiovascular events in 7.0% of men on gel versus 7.3% on placebo over a mean treatment period of 21.7 months [1][2].
What did TRAVERSE find?
Major cardiovascular events occurred in 7.0% of men on AndroGel 1.62% versus 7.3% of placebo, hazard ratio 0.96 (95% CI 0.78 to 1.17), meeting noninferiority. Mean treatment lasted 21.7 months and mean follow-up 33 months [2].
Does testosterone gel raise hematocrit?
Across 29 placebo-controlled trials with 3,393 men, gels raised mean hematocrit 3.0% versus placebo (95% CI 1.8 to 4.3), and intramuscular enanthate or cypionate raised it 4.0% [3]. The Endocrine Society recommends monitoring hematocrit during the first year [5].
Does testosterone gel raise blood pressure?
FDA says ambulatory blood pressure studies confirmed a blood pressure increase with all testosterone products, class-wide [8]. FDA also said TRAVERSE did not demonstrate a new safety signal or trend in adverse cardiovascular outcomes [1].
What does testosterone do to fertility?
Exogenous testosterone suppresses sperm production, and the Endocrine Society recommends against starting it in men planning fertility in the near term [5]. In a study of 66 men treated for infertility after testosterone use (not specific to gel), 46 (70%) reached a total motile count above 5 million within 12 months of stopping testosterone and starting high-dose hCG plus a SERM [7].

References

  1. Testosterone Information | FDA. Testosterone Information | FDA
  2. 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
  3. 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
  4. Snyder PJ, Kopperdahl DL, Stephens-Shields AJ, Ellenberg SS, Cauley JA, Ensrud KE, et al. 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. Effect of Testosterone Treatment on Volumetric Bone Density and Strength in Older Men With Low Testosterone: A Controlled Clinical Trial
  5. Bhasin S, Brito JP, Cunningham GR, Hayes FJ, Hodis HN, Matsumoto AM, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103(5):1715-1744. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline
  6. Ohlander SJ, Varghese B, Pastuszak AW. Erythrocytosis Following Testosterone Therapy. Sex Med Rev. 2018;6(1):77-85. Erythrocytosis Following Testosterone Therapy
  7. Kohn TP, Louis MR, Pickett SM, Lindgren MC, Kohn JR, Pastuszak AW, et al. Age and duration of testosterone therapy predict time to return of sperm count after human chorionic gonadotropin therapy. Fertil Steril. 2017;107(2):351-357.e1. Age and duration of testosterone therapy predict time to return of sperm count after human chorionic gonadotropin therapy
  8. FDA issues class-wide labeling changes for testosterone products | FDA. FDA issues class-wide labeling changes for testosterone products | FDA
Evidence overview for AndroGel Year-1 Outcomes: What Real Users Report After 12 Months on Testosterone Gel