Testosterone cream is plain, unesterified testosterone mixed into a cream base and rubbed onto the skin. It does the same job as a testosterone gel: the skin soaks up the hormone and releases it into the blood over the following hours. The difference is the vehicle and, above all, the regulatory status of the product.
In the US, no testosterone cream is FDA-approved. The approved skin products currently marketed are gels and a solution (the patches have been discontinued), so a testosterone cream dispensed in the US is made by a compounding pharmacy. In Australia, two registered creams exist: AndroForte 5 for men and AndroFeme 1 for women. Most of the controlled research on creams comes from those Australian products, and from low-dose creams studied in women.
This page summarizes what regulators, pharmacokinetic studies and clinical trials report about testosterone creams. It is for education only and is not medical advice. For the approved gels (AndroGel, Testogel), see the separate Testosterone Gel page.
| Property | Detail |
|---|---|
| Drug class | Androgen; testosterone itself, with no ester attached |
| US approval | None. The FDA Orange Book lists testosterone gels, solutions, a nasal gel and pellets, plus discontinued patches, a buccal tablet and injections, but no cream |
| Registered creams | AndroForte 5 (5% cream, men) and AndroFeme 1 (women), both with Australian TGA product information |
| Route | Skin of the torso or arms; scrotal skin and vaginal use have also been studied |
| Studied doses | Men: 100 mg/day is the recommended AndroForte starting dose; women: 5–10 mg/day; vaginal: 150–300 µg |
| Half-life | Circulating testosterone 10–100 minutes (AndroGel label); the skin acts as a slow-release depot |
| Compounded product quality | In one audit, only 30–50% of compounding pharmacies supplied a product within ±20% of the prescribed strength |
| US schedule | Controlled substance, Schedule III |
| WADA | Prohibited at all times (S1.1, anabolic androgenic steroids) |
What it is
The active ingredient is testosterone, the same molecule the testes make. It is not an ester such as testosterone cypionate or enanthate, so there is nothing to cleave off. What sets the rate of delivery is the skin and the vehicle.
Creams and gels differ mainly in the base:
| Feature | Approved gel (AndroGel 1% as example) | Testosterone cream |
|---|---|---|
| Base | Hydroalcoholic gel, 67% ethanol, dries quickly | Cream base; for compounded products, chosen by the pharmacy |
| Regulatory status (US) | FDA-approved, with a fixed formula and label | Not FDA-approved; compounded to order |
| Regulatory status (Australia) | Testogel registered | AndroForte 5 and AndroFeme 1 registered |
| Dose control | Metered pump or single-dose packets | Measured by volume or length of cream; varies by product |
Sources: AndroGel 1% label; FDA Orange Book data; TGA product information search.
Compounded creams
Compounding means a pharmacy prepares a drug for an individual prescription instead of dispensing a manufactured product. FDA states plainly that compounded drugs are not FDA-approved, which means “FDA does not verify the safety, effectiveness or quality” before they are marketed (FDA compounding Q&A). FDA adds that compounded drugs should only be used when a patient’s needs cannot be met by an approved drug, and that poor compounding can produce a drug with too much or too little active ingredient.
Testosterone is often compounded as part of so-called “bioidentical” hormone therapy. FDA commissioned the US National Academies to review these products, and their 2020 report examined whether the evidence supports the safety and effectiveness claims made for them (NASEM 2020; Stuenkel, Climacteric 2021).
Pharmacokinetics
Once testosterone crosses the skin it behaves like any other testosterone. The molecule itself is short-lived: the AndroGel label notes that published half-lives for circulating testosterone range from 10 to 100 minutes. Daily dosing works because the skin holds a reservoir that keeps releasing hormone for hours after each application.
AndroForte 5 vs Testogel in men
The registration study for AndroForte 5 was an open-label, randomized crossover trial in 16 men with established androgen deficiency, aged 29–73 (Wittert et al., Andrology 2016). Each man used the 5% cream and Testogel 1% gel for 30 days, with a washout of 7–14 days between them.
| Measure at day 30 | Cream / gel ratio (90% CI) |
|---|---|
| Total exposure (AUC) | 0.99 (0.86–1.14) |
| Peak level (Cmax) | 1.02 (0.84–1.24) |
| Average level (Cavg) | 0.99 (0.86–1.14) |
All three ratios fell inside the standard 80–125% bioequivalence window. DHT, estradiol, SHBG, LH and FSH did not differ significantly between the two products. In other words, at the doses tested, the registered cream delivered the same testosterone as the gel.
Scrotal application
Scrotal skin is thin and very permeable to steroids. A crossover study gave single doses of 12.5, 25 and 50 mg of testosterone cream to the scrotum of healthy men whose own testosterone had been suppressed with nandrolone decanoate (Iyer et al., Andrology 2017):
- serum testosterone peaked quickly, at 1.9–2.8 h, and rose with dose;
- 25 mg kept testosterone in the physiologic range for 16 h;
- DHT peaked at 1.2 ng/mL (≈120 ng/dL) at 4.9 h, about 2 h after the testosterone peak;
- estradiol did not change.
The authors concluded that the scrotal route needs a much lower dose than application elsewhere on the skin.
Low-dose cream in women
Seven healthy postmenopausal women used 5 mg and 10 mg of a transdermal testosterone cream daily on the upper arm, in a crossover design of 21 days per dose (Fooladi et al., Menopause 2015). With 5 mg, the median average total testosterone was 0.54 ng/mL (≈54 ng/dL). Doubling the dose to 10 mg raised the baseline-corrected average by only about 30%. Neither dose meaningfully changed DHT, estrone, estradiol or SHBG.
Regulatory status
- United States. No testosterone cream appears in the FDA Orange Book. Creams are compounded, so they carry no FDA-reviewed label. Testosterone itself is a Schedule III controlled substance in every form (21 CFR 1308.13), which includes compounded creams.
- Australia. AndroForte 5 and AndroFeme 1 both have product information documents on the TGA register (TGA).
- Sport. Testosterone is prohibited at all times under class S1.1 when administered exogenously, whatever the route (WADA 2026 Prohibited List).
What the research shows
Men with hypogonadism
There are no large outcome trials of testosterone cream in men. The evidence is pharmacokinetic: AndroForte 5 was shown to be bioequivalent to Testogel, so its expected clinical effects are those of an approved gel at the same blood levels. The outcome trials on sexual function, body composition, bone and cardiovascular safety used gels and are covered on the Testosterone Gel page.
No comparable bioequivalence data exist for compounded creams, which vary in base, strength and absorption from pharmacy to pharmacy.
Women with low sexual desire
Testosterone cream is one of the main ways testosterone has been studied in women, at doses about one-tenth of male doses.
| Trial | Design and n | Dose | Main finding |
|---|---|---|---|
| Goldstat et al., Menopause 2003 | Premenopausal women with low libido; placebo-controlled crossover, 12-week periods; 31 with complete data | 10 mg/day | Well-being score +12.9 (95% CI 4.6–21.2) and sexual self-rating +15.7 (95% CI 6.5–25.0) vs placebo |
| El-Hage et al., Climacteric 2007 | Hysterectomized postmenopausal women on estrogen with low desire; placebo-controlled crossover, 3-month periods; 36 recruited | 10 mg/day (2 cm AndroFeme) | Improved desire, frequency of sex, receptivity and initiation; no change in mood, lipids, blood pressure or weight |
A 2019 meta-analysis of 36 randomized trials (8,480 participants) pooled testosterone across routes (Islam et al., Lancet Diabetes Endocrinol 2019). In postmenopausal women, testosterone increased satisfying sexual events by 0.85 per month (95% CI 0.52–1.18) and improved desire, arousal and orgasm. Oral testosterone worsened cholesterol, but non-oral forms such as patches and creams did not.
The 2019 Global Consensus Position Statement, endorsed by the Endocrine Society and major menopause societies, concluded that the only evidence-based indication for testosterone in women is hypoactive sexual desire disorder (HSDD, distressing low sexual desire) after menopause (Davis et al., JCEM 2019). On creams specifically, it said:
- compounded “bioidentical” testosterone “cannot be recommended” for HSDD because of a lack of evidence for efficacy and safety, unless no authorized equivalent is available;
- if a compounded product must be used, the pharmacy should meet Good Manufacturing Practice standards;
- dosing should keep blood levels in the physiologic premenopausal range.
Vaginal testosterone cream with aromatase inhibitors
Aromatase inhibitors, used to treat hormone receptor-positive breast cancer, are associated with significant vaginal atrophy. Because it is debated whether vaginal estrogen could interfere with these drugs, vaginal testosterone cream has been tested as a non-estrogen alternative:
| Trial | Design and n | Dose | Main finding |
|---|---|---|---|
| Witherby et al., Oncologist 2011 | Phase I/II, 21 women, 28 days | 150 or 300 µg daily | Symptom score fell from 2.0 to 0.7; estradiol stayed under 8 pg/mL |
| Melisko et al., JAMA Oncol 2017 | Randomized vs estradiol vaginal ring, 75 started, 12 weeks | Vaginal testosterone cream | Persistent estradiol rise in 4 of 34 (12%) on testosterone vs none on the ring; symptoms improved in both arms |
| Davis et al., JCEM 2018 | Double-blind, placebo-controlled, 44 randomized, 26 weeks | 300 µg daily for 2 weeks, then 3 times weekly | Sexual satisfaction +0.73 units vs placebo (95% CI 0.02–1.43); less dryness and pain with sex; serum sex steroids unchanged |
These are small trials. They support further study, not routine use.
Lichen sclerosus: an abandoned use
Topical testosterone has been tested for genital lichen sclerosus, a chronic inflammatory skin disease. A Cochrane review found no significant benefit from topical testosterone, dihydrotestosterone or progesterone across four trials. In another trial, testosterone used as maintenance after clobetasol made symptoms worse, while placebo did not (Chi et al., Cochrane 2011). The same review found the potent corticosteroids clobetasol propionate and mometasone furoate effective.
Performance in young women
A double-blind trial randomized 48 physically active women aged 18–35 to 10 mg testosterone cream daily or placebo for 10 weeks (Hirschberg et al., Br J Sports Med 2020). Testosterone rose from 0.9 to 4.3 nmol/L (≈26 to 124 ng/dL).
| Outcome | Testosterone | Placebo |
|---|---|---|
| Running time to exhaustion | +21.2 s (+8.5%) | Between-group difference 15.5 s (p = 0.045) |
| Total lean mass | +923 g | +135 g (p = 0.040) |
| Wingate average power | +15.2 W | +3.2 W (not significant) |
| Jump height and knee strength | No significant change | No significant change |
Even a low-dose cream producing only a moderate rise in testosterone measurably improved endurance and lean mass. This is part of the reason testosterone is banned in sport regardless of dose or route.
Side effects and risks
Transfer to children and partners
The main hazard of any skin testosterone product is transfer by touch. The FDA-approved gels carry a boxed warning that children have been virilized after secondary exposure (AndroGel 1% label). Compounded creams have no FDA label at all, but case reports show the same problem:
| Report | Child | Testosterone in child | After exposure stopped |
|---|---|---|---|
| Stephen et al., Endocr Pract 2008 | Boy, 2 years 7 months; pubic hair, rapid growth, advanced bone age | 371 ng/dL (prepubertal normal: under 3–10 ng/dL) | 10 ng/dL |
| Georges et al., J Pediatr Endocrinol Metab 2023 | Boy, 3.5 years; penile growth, growth spurt; father used compounded cream | 1,460 ng/dL | 20 ng/dL within 2 months |
| Franklin, Pediatr Endocrinol Rev 2011 | Twin boys; gynecomastia, rapid growth, pubic hair in one | Mother used compounded estradiol, estrone and testosterone creams | — |
The AndroGel label’s advice applies equally to creams: children and women should avoid contact with unwashed or unclothed application sites.
Dosing accuracy of compounded products
In a blinded audit, researchers presented the same prescription for a 50 mg daily testosterone gel or cream to 10 compounding pharmacies in Toronto and tested two batches from each a month apart (Grober et al., J Sex Med 2015):
- the pharmacies supplied 7 gels and 3 creams;
- only 50% (first batch) and 30% (second batch) were within ±20% of the prescribed strength;
- two pharmacies supplied products more than 20% too strong, and one supplied a product with essentially no testosterone;
- the approved gels used as controls, AndroGel and Testim, were consistent and accurate.
This variability means blood levels on a compounded cream can drift between refills without any change in how the patient uses it.
Systemic effects
Once absorbed, testosterone from a cream has the same effects and risks as testosterone from any other route. The AndroGel label’s warnings include polycythemia (a rise in hematocrit, the share of blood made up of red cells), worsening of benign prostatic hyperplasia, blood pressure increases, venous thromboembolism, suppression of sperm production, edema and gynecomastia (AndroGel 1% label). In a retrospective study of 72 transgender and gender-diverse adults using AndroForte 5, the median testosterone reached was 11.9 nmol/L (≈343 ng/dL), and polycythemia (too many red cells) was documented in 5 people (7%) (Nolan et al., J Sex Med 2022). That study also noted that more than half of patients started below the 100 mg/day dose recommended for hypogonadal men.
In women at physiologic doses, the meta-analysis found more acne and hair growth than with placebo, but no serious adverse events (Islam et al. 2019). The consensus statement adds that long-term safety data in women beyond 24 months are lacking, and that women with prior breast cancer were excluded from the HSDD trials (Davis et al. 2019).
For the full list of labeled warnings for skin testosterone in men, including blood pressure, hematocrit and prostate monitoring, see the Testosterone Gel page.
Key takeaways
- Same hormone, different vehicle. Testosterone cream contains plain testosterone; only the base differs from a gel.
- No FDA-approved cream. In the US, testosterone creams are compounded and not FDA-reviewed. Australia has two registered creams, AndroForte 5 and AndroFeme 1.
- The registered cream matches the gel. AndroForte 5 was bioequivalent to Testogel in hypogonadal men, with AUC and peak ratios close to 1.0.
- Compounded strength is unreliable. In one audit, only 30–50% of pharmacies supplied a product within ±20% of the prescribed dose, and one supplied almost no testosterone.
- Women’s evidence is real but narrow. Low-dose creams improve sexual function in postmenopausal women with HSDD; guidelines advise against compounded products when an approved option exists.
- Transfer can virilize children. Case reports document adult-level testosterone in toddlers exposed to a parent’s cream, falling back to normal once exposure stopped.
Sources
- Besins Healthcare / ASCEND Therapeutics. AndroGel (testosterone gel) 1%, prescribing information. DailyMed.
- US Food and Drug Administration. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), product data file. FDA.
- Therapeutic Goods Administration. Product Information search: testosterone (AndroForte 5, AndroFeme 1). TGA.
- US Food and Drug Administration. Compounding and the FDA: questions and answers. FDA.
- National Academies of Sciences, Engineering, and Medicine; Jackson LM, Parker RM, Mattison DR, eds. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: National Academies Press; 2020. PubMed.
- Stuenkel CA. Compounded bioidentical menopausal hormone therapy - a physician perspective. Climacteric. 2021;24(1):11–18. PubMed.
- Wittert GA, Harrison RW, Buckley MJ, Wlodarczyk J. An open-label, phase 2, single centre, randomized, crossover design bioequivalence study of AndroForte 5 testosterone cream and Testogel 1% testosterone gel in hypogonadal men: study LP101. Andrology. 2016;4(1):41–45. PubMed.
- Iyer R, Mok SF, Savkovic S, et al. Pharmacokinetics of testosterone cream applied to scrotal skin. Andrology. 2017;5(4):725–731. PubMed.
- Fooladi E, Reuter SE, Bell RJ, et al. Pharmacokinetics of a transdermal testosterone cream in healthy postmenopausal women. Menopause. 2015;22(1):44–49. PubMed.
- US Drug Enforcement Administration. Schedules of controlled substances: Schedule III, 21 CFR 1308.13. eCFR.
- World Anti-Doping Agency. World Anti-Doping Code International Standard: Prohibited List 2026. WADA 2026 Prohibited List.
- Goldstat R, Briganti E, Tran J, et al. Transdermal testosterone therapy improves well-being, mood, and sexual function in premenopausal women. Menopause. 2003;10(5):390–398. PubMed.
- El-Hage G, Eden JA, Manga RZ. A double-blind, randomized, placebo-controlled trial of the effect of testosterone cream on the sexual motivation of menopausal hysterectomized women with hypoactive sexual desire disorder. Climacteric. 2007;10(4):335–343. PubMed.
- Islam RM, Bell RJ, Green S, et al. Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomised controlled trial data. Lancet Diabetes Endocrinol. 2019;7(10):754–766. PubMed.
- Davis SR, Baber R, Panay N, et al. Global Consensus Position Statement on the Use of Testosterone Therapy for Women. J Clin Endocrinol Metab. 2019;104(10):4660–4666. PubMed; PMC.
- Witherby S, Johnson J, Demers L, et al. Topical testosterone for breast cancer patients with vaginal atrophy related to aromatase inhibitors: a phase I/II study. Oncologist. 2011;16(4):424–431. PubMed.
- Melisko ME, Goldman ME, Hwang J, et al. Vaginal testosterone cream vs estradiol vaginal ring for vaginal dryness or decreased libido in women receiving aromatase inhibitors for early-stage breast cancer: a randomized clinical trial. JAMA Oncol. 2017;3(3):313–319. PubMed.
- Davis SR, Robinson PJ, Jane F, et al. Intravaginal testosterone improves sexual satisfaction and vaginal symptoms associated with aromatase inhibitors. J Clin Endocrinol Metab. 2018;103(11):4146–4154. PubMed.
- Chi CC, Kirtschig G, Baldo M, et al. Topical interventions for genital lichen sclerosus. Cochrane Database Syst Rev. 2011;(12):CD008240. PubMed.
- Hirschberg AL, Elings Knutsson J, Helge T, et al. Effects of moderately increased testosterone concentration on physical performance in young women: a double blind, randomised, placebo controlled study. Br J Sports Med. 2020;54(10):599–604. PubMed.
- Stephen MD, Jehaimi CT, Brosnan PG, Yafi M. Sexual precocity in a 2-year-old boy caused by indirect exposure to testosterone cream. Endocr Pract. 2008;14(8):1027–1030. PubMed.
- Georges E, Cedarbaum V, Bisno DI, Marshall I. Sexual precocity in the setting of parental use of a compounded testosterone cream: case report and review of the literature. J Pediatr Endocrinol Metab. 2023;36(3):323–326. PubMed.
- Franklin SL. Effects of unintentional exposure of children to compounded transdermal sex hormone therapy. Pediatr Endocrinol Rev. 2011;8(3):208–212. PubMed.
- Grober ED, Garbens A, Božović A, et al. Accuracy of testosterone concentrations in compounded testosterone products. J Sex Med. 2015;12(6):1381–1388. PubMed.
- Nolan BJ, Zwickl S, Locke P, et al. Prescription patterns and testosterone concentrations achieved with AndroForte 5% testosterone cream in transgender and gender diverse individuals. J Sex Med. 2022;19(6):1049–1054. PubMed.