AndroGel What to Expect: Week-by-Week First Month Guide

At a glance

• Label form / testosterone gel 1%, not the 1.62% gel [1]
• Starting dose, 1% gel / 50 mg once daily in the morning [1]
• Application sites / shoulders, upper arms and/or abdomen; not genitals, chest, armpits, knees or back [1]
• Shower or swim / avoid for at least 5 hours after application [1]
• Boxed warning / virilization reported in children secondarily exposed to testosterone gel [1]
• Monitoring / hematocrit before starting, at 3 to 6 months, then annually; other labs periodically [1]
• Week-by-week timeline / not in the 1% label; the T-Trials report results at 1 year [1][3]

Is There a Week-by-Week Timeline?

The 1% label gives no week 1 to week 4 schedule for energy, mood, libido or erections [1]. The T-Trials, described below, reported outcomes after 1 year of gel, and TRAVERSE after a mean of 21.7 months of treatment [3][4]. The 1% label says its dosing differs from testosterone gel 1.62%, which has its own prescribing information [1].

What the 1% Label Covers

This page uses the label for generic testosterone gel 1%. Its starting dose is 50 mg once daily in the morning, applied to clean, dry, intact skin of the shoulders, upper arms and/or abdomen [1]. The label says not to apply the gel to the genitals, chest, armpits, knees or back [1]. It says to let the gel dry before dressing, wash hands thoroughly, and avoid fire, flames or smoking until the gel dries because alcohol-based gel is flammable, and to avoid swimming or showering for at least 5 hours after application [1].

The boxed warning is secondary exposure: virilization has been reported in children exposed to testosterone gel, and children should avoid contact with unwashed or unclothed application sites [1].

What to Watch For

The label lists acne, application-site reaction, abnormal lab tests and prostatic disorders as the most common adverse reactions (incidence 5% or more) [1]. Its adverse event tables come from a 180-day trial and a 3-year extension, not from a first-month breakdown [1]. It warns that testosterone gel can raise blood pressure and is not recommended in uncontrolled hypertension; in an ambulatory blood pressure monitoring study of the 1% gel, mean systolic/diastolic pressure rose 1.9/1.3 mm Hg from baseline after 16 weeks [1]. Venous thromboembolism, edema and sleep apnea are also listed warnings [1].

The label says check hematocrit before starting, re-evaluate at 3 to 6 months, then annually, and monitor serum testosterone, PSA, hemoglobin, hematocrit, liver function tests and lipids periodically [1]. The 1% label also warns that exogenous androgens may lead to azoospermia, and the Endocrine Society guideline recommends against starting testosterone in men planning fertility in the near term [1][2].

What Longer Studies Show

The T-Trials assigned 790 symptomatic men aged 65 or older with testosterone below 275 ng/dL to testosterone gel or placebo for 1 year [3]. Testosterone increased sexual activity, sexual desire and erectile function; it had no significant benefit for vitality, though men on testosterone reported slightly better mood and lower severity of depressive symptoms [3]. Results were reported at 1 year, not week by week.

TRAVERSE randomized 5,246 men aged 45 to 80 with hypogonadism and cardiovascular disease or high risk to daily 1.62% testosterone gel or placebo [4]. Major adverse cardiovascular events occurred in 7.0% on testosterone and 7.3% on placebo; mean treatment was 21.7 months and follow-up 33 months [4]. Mean systolic pressure rose 1.0 mm Hg on testosterone versus a 0.5 mm Hg fall on placebo at 36 months [4].

Frequently asked questions

›When will I feel testosterone gel working?

The 1% label gives no schedule for when symptoms change. In the 1-year T-Trials of 790 men aged 65 or older, testosterone gel improved sexual activity, desire and erectile function but had no significant benefit for vitality, and results were reported at 1 year, not at weeks 1 to 4 [1][3].

›How is testosterone gel 1% applied?

The label says the starting dose is 50 mg once daily in the morning, applied to clean, dry, intact skin of the shoulders, upper arms and/or abdomen, and not to the genitals, chest, armpits, knees or back. It says to let the gel dry before dressing and to wash hands thoroughly [1].

›Can I shower after applying it?

The 1% label says to avoid swimming or showering for at least 5 hours after application [1].

›What blood tests does the label mention?

The label says to check hematocrit before starting, re-evaluate at 3 to 6 months, then annually, and to monitor serum testosterone, PSA, hemoglobin, hematocrit, liver function tests and lipids periodically [1].

›What is the boxed warning?

The boxed warning says virilization has been reported in children secondarily exposed to testosterone gel, and that children should avoid contact with unwashed or unclothed application sites [1].

References

1. 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
2. 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
3. Snyder PJ, Bhasin S, Cunningham GR, Matsumoto AM, Stephens-Shields AJ, Cauley JA, et al. Effects of Testosterone Treatment in Older Men. N Engl J Med. 2016;374(7):611-24. Effects of Testosterone Treatment in Older Men
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