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AndroGel Month-by-Month: What to Expect in Your First 3 Months

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At a glance

  • What the data cover / a 180-day study of testosterone gel 1% in 227 men, plus the generic testosterone gel 1.62% label [1][2]
  • Earliest measured change / sexual function and mood improved maximally by day 30 [1]
  • Body composition at 90 days / lean mass +2.74 kg with 100 mg/day and +1.28 kg with 50 mg/day [1]
  • Starting dose, 1.62% gel label / 40.5 mg once daily, 2 pump actuations [2]
  • Application site, 1.62% gel label / shoulders and upper arms only [2]
  • Hematocrit, per the label / check before starting; re-evaluate 3 to 6 months after starting [2]
  • Blood pressure at week 16 / mean 24-hour rise of 1.9/1.3 mm Hg [2]
  • Fertility warning / exogenous androgens may lead to azoospermia [2]

What Timing Data Exist for Testosterone Gel?

The most direct timing data come from a 180-day study of testosterone gel 1% (50 or 100 mg/day) compared with a testosterone patch in 227 hypogonadal men [1]. It is not an AndroGel-specific symptom diary. The 1.62% dosing and safety details below come from the generic testosterone gel 1.62% label, not from a brand-specific AndroGel label [2].

Month 1: What Happens by Day 30

In that 180-day study, sexual function and mood improved maximally on day 30, without differences across the gel and patch groups, and showed no further improvement with continued treatment [1].

Month 3: Body Composition and Strength

At 90 days in the 1% gel study, lean body mass rose by 2.74 kg with 100 mg/day, 1.28 kg with 50 mg/day and 1.20 kg with the patch [1]. Fat mass decreased in both gel groups (-1.05 kg and -0.90 kg) but not significantly in the patch group [1]. Leg press strength rose 11 to 13 kg by 90 days across groups and did not improve further at 180 days [1].

Safety Rates Over the 182-Day Trial

The 1.62% gel label reports a 182-day double-blind period with 234 men on active gel and 40 on placebo. Adverse reactions reported in more than 2% of men and more often than with placebo were PSA increased 11.1%, emotional lability 2.6%, hypertension 2.1%, hematocrit or hemoglobin increased 2.1%, and contact dermatitis 2.1% [2]. Application site reactions were reported in 0.9% [2]. These are rates for the whole period, not for any single month [2].

Monitoring

The label says it would be appropriate to check hematocrit before starting, re-evaluate it 3 to 6 months after starting, and then annually [2]. It also says to monitor serum testosterone, PSA, hemoglobin, hematocrit, liver function tests and lipids periodically [2]. The Endocrine Society guideline recommends monitoring symptoms, serum testosterone, hematocrit and prostate cancer risk in the first year [3].

What to Watch For

The 1.62% label warns that testosterone gel can increase blood pressure. In an ambulatory blood pressure study, it raised mean 24-hour systolic/diastolic pressure by 1.9/1.3 mm Hg at week 16, and by 3.0/2.2 mm Hg in men with hypertension on treatment [2]. It is not recommended for men with uncontrolled hypertension [2]. The label also warns about secondary exposure: children should avoid contact with unwashed or unclothed application sites, and virilization has been reported in children exposed to testosterone gel [2]. Venous thromboembolism has been reported, and the label says to evaluate symptoms of DVT or PE [2]. In TRAVERSE, 5,246 men took 1.62% testosterone gel or placebo; major adverse cardiovascular events occurred in 7.0% versus 7.3% (HR 0.96, 95% CI 0.78 to 1.17) [4].

Frequently asked questions

What should I expect by week 4 on AndroGel?
The clearest data come from a 180-day study of testosterone gel 1%, not AndroGel 1.62%. In that study of 227 men, sexual function and mood improved maximally by day 30 and did not improve further through 180 days [1].
What labs does the 1.62% gel label mention?
The label says it would be appropriate to check hematocrit before starting, re-evaluate it 3 to 6 months after starting, and then annually. It also says to monitor serum testosterone, PSA, hemoglobin, hematocrit, liver function tests and lipids periodically [2].
Can testosterone gel affect fertility?
The label warns that exogenous androgens may lead to azoospermia [2]. The Endocrine Society guideline recommends against starting testosterone therapy in men planning fertility in the near term [3].
What is the starting dose for 1.62% gel?
The generic 1.62% gel label lists a starting dose of 40.5 mg once daily (two pump actuations or one 40.5 mg packet), applied to clean, dry skin of the shoulders and upper arms [2].

References

  1. Wang C, Swerdloff RS, Iranmanesh A, Dobs A, Snyder PJ, Cunningham G, et al. Transdermal testosterone gel improves sexual function, mood, muscle strength, and body composition parameters in hypogonadal men. J Clin Endocrinol Metab. 2000;85(8):2839-53. Transdermal testosterone gel improves sexual function, mood, muscle strength, and body composition parameters in hypogonadal men
  2. U.S. National Library of Medicine, DailyMed. Testosterone gel 1.62% topical, generic (Padagis), prescribing information. Testosterone gel 1.62% topical, generic (Padagis) label
  3. 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
  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
Evidence overview for AndroGel Month-by-Month: What to Expect in Your First 3 Months