AndroGel Sexual Function Impact: What the Clinical Evidence Actually Shows

What the largest trial of testosterone gel found

The Testosterone Trials enrolled 790 men aged 65 or older with a serum testosterone below 275 ng/dL and symptoms suggesting low testosterone. Each man joined one or more of three trials, one of which was a Sexual Function Trial, and received testosterone gel or placebo gel for one year [1]. Treatment raised serum testosterone into the mid-normal range for men aged 19 to 40 [1].

Sexual activity measured on the Psychosexual Daily Questionnaire increased significantly (P<0.001), and sexual desire and erectile function both improved [1]. The investigators summarised the result as a moderate benefit with respect to sexual function, and noted that the number of participants was too few to draw conclusions about the risks of treatment [1].

FDA-approved testosterone products are approved only for men who have low testosterone together with an associated medical condition, and the labels have said safety and efficacy in age-related hypogonadism are not established; in June 2026 FDA asked sponsors to remove that limitation of use [6].

How large is the effect on erections?

Moderate at best, and it depends heavily on who is being treated.

A meta-analysis of 17 placebo-controlled trials (656 men, median 3 months) found that in men whose average baseline testosterone was below 12 nmol/L, testosterone moderately improved the number of nocturnal erections, sexual thoughts and motivation, the number of successful intercourses, erectile function scores and overall sexual satisfaction. In eugonadal men it had no effect on erectile function [2].

A later meta-analysis of 41 trials (29 against placebo and 12 as add-on to PDE5 inhibitors) found that testosterone significantly ameliorated erectile function and improved other aspects of the male sexual response in hypogonadal men. That result came with caveats: after a trim-and-fill adjustment for publication bias, the positive effect on erectile function and libido remained significant only in trials partly or completely supported by pharmaceutical companies, and most included studies mixed eugonadal with hypogonadal men, so the role of testosterone is uncertain in men who are not clearly hypogonadal [5].

When sildenafil alone has not worked

A randomized, double-blind, placebo-controlled trial enrolled 75 hypogonadal men aged 18 to 80 with a morning total testosterone of 400 ng/dL or less and a confirmed lack of response to sildenafil alone. They received daily 1% testosterone gel or 5 g of placebo gel on top of sildenafil 100 mg for 12 weeks [3].

Erectile function on the IIEF improved more with testosterone gel than with placebo, reaching significance at week 4 (4.4 versus 2.1 points, p=0.029; 95.1% CI 0.3 to 4.7). Similar trends appeared for orgasmic function, overall satisfaction, total IIEF score and the proportion of IIEF responders. No significant correlation was found between testosterone levels and IIEF scores at the end of treatment, and the authors concluded that testosterone gel with sildenafil may be beneficial in men unresponsive to sildenafil alone [3].

How soon does libido improve?

The first significant difference in the sildenafil add-on study came at week 4 [3]. In a pharmacokinetic study of 227 hypogonadal men, by comparison, serum testosterone rose into the normal adult male range on day one and steady state was reached 48 to 72 hours after the first gel application [7]. The one-year trial reports improved sexual function over the year without giving a time of onset [1].

Does a higher level mean better sex?

Not in any simple way. In the sildenafil add-on trial, testosterone levels at the end of treatment did not correlate significantly with IIEF scores [3].

What the population data do show is an association at the bottom of the range. In 3,369 men aged 40 to 79 across eight European centres, poor morning erections, low sexual desire and erectile dysfunction were the symptoms most closely tied to a low testosterone level, and late-onset hypogonadism was defined as at least three sexual symptoms with a total testosterone below 11 nmol/L (3.2 ng/mL) and a free testosterone below 220 pmol/L [8]. That is a diagnostic threshold, not a treatment target.

Fertility

Exogenous testosterone suppresses pituitary luteinizing hormone and, at large doses, follicle-stimulating hormone, which suppresses sperm production. The Endocrine Society recommends against starting testosterone therapy in men who plan fertility in the near term [4].

Recovery after stopping is possible but variable. In a retrospective series of 66 men with infertility after testosterone use, all stopped testosterone and received high-dose hCG plus a selective estrogen receptor modulator; 46 (70%) reached a total motile count above 5 million within 12 months. Only 64.8% of azoospermic men did, against 91.7% of cryptozoospermic men, and older age and longer prior testosterone use predicted slower recovery [9]. In a separate series of 49 men with azoospermia or severe oligospermia while on testosterone, treated with hCG 3,000 units subcutaneously every other day plus clomiphene, tamoxifen, anastrozole or recombinant FSH, spermatogenesis returned or improved in 47 (95.9%), on average after 4.6 months, with a mean first sperm density of 22.6 million/mL [10].