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How to Safely Stop AndroGel: A Step-by-Step Discontinuation Guide

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At a glance

  • Label covered / generic testosterone gel 1% (Teva), not AndroGel's own label [1]
  • Label stop triggers / suspected VTE; elevated hematocrit (stop until it decreases to an acceptable concentration) [1]
  • Label monitoring / serum testosterone, PSA, hemoglobin, hematocrit, liver tests, lipids [1]
  • Fertility recovery data / hCG plus a SERM after testosterone use, not simple stopping [2]
  • Sperm recovery timeline / healthy men on hormonal contraception, not men treated for hypogonadism [3]

Is there a step-by-step taper for AndroGel?

The evidence on this page describes no AndroGel taper and no comparison of tapering with stopping at once, so a step-by-step schedule is a clinical judgement rather than something established by published data.

The generic testosterone gel 1% label does give specific reasons to stop treatment. It says that if a venous thromboembolic event is suspected, discontinue testosterone gel 1% and initiate appropriate workup and management [1]. It says that if hematocrit becomes elevated, therapy should be stopped until hematocrit decreases to an acceptable concentration [1]. It also says testosterone gel 1% can increase blood pressure and is not recommended in patients with uncontrolled hypertension [1]. For secondary exposure, it says the gel should be promptly discontinued until the cause of virilization is identified [1].

What does the label say to monitor?

The label says to monitor serum testosterone, PSA, hemoglobin, hematocrit, liver function tests and lipid concentrations periodically [1]. It gives no post-discontinuation lab schedule.

How long can sperm production take to recover?

The label warns that exogenous administration of androgens may lead to azoospermia [1]. The recovery timelines below come from other settings, not from a study of stopping AndroGel.

In 1,549 healthy men using hormonal male contraception, sperm concentration recovered to 20 million/mL at a median of 3.4 months; 67% reached that threshold by 6 months and 90% by 12 months [3]. These were healthy men with normal testosterone, not men treated for hypogonadism, so their recovery times cannot be assumed to apply to stopping AndroGel [3].

After testosterone-associated infertility, 66 men 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, and older age and longer testosterone use were associated with slower recovery [2]. In a separate series of 49 men with azoospermia or severe oligospermia while on testosterone, hCG 3,000 units subcutaneously every other day plus clomiphene, tamoxifen, anastrozole or recombinant FSH returned or improved spermatogenesis in 47 (95.9%), at an average of 4.6 months [4].

Frequently asked questions

What does the generic gel 1% label say about elevated hematocrit?
It says that if hematocrit becomes elevated, therapy should be stopped until hematocrit decreases to an acceptable concentration [1].
What monitoring does the generic gel 1% label call for?
It calls for periodic checks of serum testosterone, PSA, hemoglobin, hematocrit, liver function tests and lipids; it does not give a post-stop schedule [1].
Will sperm production recover after stopping testosterone?
The label warns that exogenous androgens may lead to azoospermia [1]. In 1,549 healthy men on hormonal contraception, median recovery to 20 million/mL was 3.4 months; 67% reached it by 6 months and 90% by 12 months [3]. In men treated after testosterone-associated infertility, older age and longer testosterone use were associated with slower recovery [2].
Can hCG-based treatment help after stopping testosterone?
In 66 men with infertility after testosterone use, hCG plus a SERM produced a total motile count above 5 million in 70% within 12 months [2].

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. 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
  3. Liu PY, Swerdloff RS, Christenson PD, Handelsman DJ, Wang C, Hormonal Male Contraception Summit Group. Rate, extent, and modifiers of spermatogenic recovery after hormonal male contraception: an integrated analysis. Lancet. 2006;367(9520):1412-20. Rate, extent, and modifiers of spermatogenic recovery after hormonal male contraception: an integrated analysis
  4. Wenker EP, Dupree JM, Langille GM, Kovac J, Ramasamy R, Lamb D, et al. The Use of HCG-Based Combination Therapy for Recovery of Spermatogenesis after Testosterone Use. J Sex Med. 2015;12(6):1334-7. The Use of HCG-Based Combination Therapy for Recovery of Spermatogenesis after Testosterone Use
  5. Katz DJ, Nabulsi O, Tal R, Mulhall JP. Outcomes of clomiphene citrate treatment in young hypogonadal men. BJU Int. 2012;110(4):573-8. Outcomes of clomiphene citrate treatment in young hypogonadal men
Evidence overview for How to Safely Stop AndroGel: A Step-by-Step Discontinuation Guide