CreamTransdermalNon sterile Rx only

Testosterone Topical BHRT Cream

Topical Cream Base

A compounded testosterone cream, prepared in Chino, CA in the base a prescriber specifies. Testosterone is a Schedule III controlled substance.

Reviewed by Linda Pungpravat, Compounding Pharmacist, RPh Mixwell Compounding Pharmacy, Chino, CA

USP <795> compliant
USP <800> hazardous drug lab
PCCA member

At a Glance

Preparation details for Testosterone Topical BHRT Cream
Dosage form	Cream
Route	Transdermal
Active ingredients	Testosterone
Technology	Topical Cream Base
Strengths in literature	1.62% gel in the TRAVERSE trial, adjusted to keep blood levels at 350 to 750 ng/dL. For women, guidelines target premenopausal blood levels.
Commercial product	Commercial product in a different dosage form
Strength and directions	Per prescriber
Dispensing	Valid prescription

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Phone (909) 378-7301. Fax (909) 378-7071

Clinical Advantages

Custom strength available
Dye free option
Non sterile preparation
Applied topically

How It Works

What is Testosterone Topical BHRT Cream?

Testosterone Topical BHRT Cream is a compounded testosterone cream prepared in the base the prescriber specifies, such as Lipoderm or VersaBase cream or Atrevis hydrogel. It is prepared by prescription, at the strength the prescriber sets, for adult men with confirmed low testosterone and, under specialist supervision, for some postmenopausal women. Testosterone is a Schedule III controlled substance [2].

The word bioidentical describes the molecule, which matches the testosterone the body makes. FDA approved testosterone gels contain the same molecule, so the term says nothing about whether a compounded cream is safer, stronger, or better than an approved product [2][7].

How it works

Applied to the skin, testosterone is absorbed into the bloodstream, which is how approved testosterone gels work [2].
The prescriber chooses the base, with the pharmacist's help. The choice of base does not change the drug or the safety precautions.
Absorption from a compounded cream is not standardized the way it is for approved gels, so guidelines call for checking blood testosterone during treatment [4][5][7].
Testosterone can pass from treated skin to another person through direct contact, which is why approved gels carry a boxed warning [2].

When prescribers choose it

Endocrinologists, urologists, and men's health clinics treating adult men with confirmed low testosterone who need a cream or a strength the approved gels do not offer
Menopause specialists and gynecologists treating postmenopausal women with diagnosed hypoactive sexual desire disorder, with blood levels monitored
Prescribers whose patients react to an ingredient in an approved gel or patch
Practices that prefer a cream to a gel, patch, or troche

Clinical Details

What does the evidence show?

The FDA states that testosterone is approved solely for men with low testosterone and an associated medical condition. Approved forms are oral, topical gel, transdermal patch, buccal system, and injection. Cream is not among them, and no testosterone product for women is approved [1].
The AUA and Endocrine Society guidelines define testosterone deficiency in men as symptoms plus a total testosterone below 300 ng/dL, confirmed on repeated morning blood tests, and do not support treating men with normal levels [5][6].
In the TRAVERSE trial (Lincoff and colleagues, 2023, New England Journal of Medicine), 5,246 men aged 45 to 80 with low testosterone and heart disease or a high risk of it used a 1.62% testosterone gel or a placebo gel. Major adverse cardiac events were similar, but atrial fibrillation, acute kidney injury, and pulmonary embolism were more common with testosterone [3]. This was a study of an approved gel, not a compounded cream. In February 2025 the FDA removed language about increased cardiovascular risk from the boxed warning on testosterone products and required a blood pressure warning on all of them [1].
The 2019 global consensus position statement on testosterone for women (Davis and colleagues, a task force of international menopause, sexual medicine, and endocrine societies) found that the only evidence based indication is hypoactive sexual desire disorder in postmenopausal women after a full assessment. It calls for doses that approximate premenopausal blood levels with regular monitoring, and notes there are no safety data beyond 24 months. It also states that no testosterone product for women is approved by any national regulator, that male formulations can be used judiciously in small doses with monitoring, and that compounded testosterone should not be used if a regulatory approved product is available [4].

Findings come from the cited studies and do not promise any individual outcome.

Why is it compounded, and how is it typically used?

Why it is compounded

No testosterone cream is FDA approved. The approved topical forms are gels and patches, labeled only for adult men with low testosterone, and none is approved for women [1][2]. A prescriber who wants a cream, a strength the gels do not offer, or testosterone for a postmenopausal woman orders it compounded. Federal law restricts compounding preparations that are essentially copies of approved products unless the prescriber documents a significant difference for that patient [8].

Testosterone is a Schedule III controlled substance, which affects how prescriptions are written, transmitted, and refilled [2].

Dosage forms and strengths

Strength set by the prescriber. For comparison, an approved men's gel supplies 20.25 mg of testosterone per pump actuation at 1.62%, and guidance for women calls for doses that reach premenopausal blood levels [2][4]
Base specified by the prescriber: Lipoderm or VersaBase cream, or Atrevis hydrogel
Dye free versions on request
Quantities matched to the prescribed course and monitoring schedule

Dosing, blood level monitoring, and duration are the prescriber's decision.

How Mixwell prepares it

Mixwell compounds this cream in Chino, California under USP 795 standards for non sterile preparations, in a facility with a USP 800 negative pressure containment room [9]. Our pharmacist reviews the strength, application directions, and skin contact precautions with the prescriber before compounding. Batch records document every preparation, and finished creams ship across California.

Safety information

Approved topical testosterone gels carry a boxed warning about secondary exposure. Children touched by treated skin have developed virilization, including enlargement of the penis or clitoris, pubic hair, aggressive behavior, and advanced bone age, and in a few cases the changes did not fully reverse [2]. The same transfer risk applies to any testosterone applied to the skin, including a compounded cream. Children and women should avoid contact with unwashed or unclothed application sites, hands should be washed right after applying, and the site should be covered with clothing once dry [2].

Testosterone is contraindicated in pregnancy because it may cause fetal harm, and in men with breast cancer or known or suspected prostate cancer [2]. All testosterone products now carry a warning that they can raise blood pressure [1]. Labeling also describes blood clots in the veins and lungs, lowered or stopped sperm production, swelling in people with heart, kidney, or liver disease, and sleep apnea [2].

In women, doses that reach premenopausal blood levels were linked in trials to mild increases in acne and body or facial hair in some women, without scalp hair loss or voice change, and no safety data exist beyond 24 months. Blood testosterone is monitored regularly [4].

Absorption from a compounded cream is not standardized, and compounded preparations lack the uniform labeling and warnings of approved products [7]. Patient selection, dosing, monitoring, and duration are the prescriber's responsibility.

References

U.S. Food and Drug Administration. FDA issues class wide labeling changes for testosterone products. February 28, 2025. FDA
ANDROGEL (testosterone gel) 1.62%. Prescribing information. Drugs.com label
Lincoff AM, Bhasin S, Flevaris P, et al. Cardiovascular safety of testosterone replacement therapy. N Engl J Med. 2023;389(2):107 to 117. doi:10.1056/NEJMoa2215025
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 to 4666. doi:10.1210/jc.2019-01603
Bhasin S, Brito JP, Cunningham GR, et al. Testosterone therapy in men with hypogonadism: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2018;103(5):1715 to 1744. doi:10.1210/jc.2018-00229
Mulhall JP, Trost LW, Brannigan RE, et al. Evaluation and management of testosterone deficiency: AUA guideline. J Urol. 2018;200(2):423 to 432.
National Academies of Sciences, Engineering, and Medicine. The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use. Washington, DC: National Academies Press; 2020. doi:10.17226/25791
U.S. Food and Drug Administration. Compounding when drugs are on FDA's drug shortages list. FDA human drug compounding
United States Pharmacopeia. General Chapters 795 and 800. USP NF.

What to include on the prescription

APIs and strengths
Base or vehicle
Quantity
Directions for use
Refills
Allergies or dye free needs

Call (909) 378-7301 Fax (909) 378-7071

Compounded in Chino, CA. Delivered across California.

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Mixwell Compounding Pharmacy 13788 Roswell Ave, Ste 158, Chino, CA 91710
(909) 378-7301

Compounded medications are not reviewed or approved by the FDA. Dispensed only with a valid prescription. Mixwell is a non sterile pharmacy and does not prepare sterile products or injectables. Compounded preparations are not presented as superior to commercially available products, and nothing here promises a specific result. Mixwell does not accept insurance. Call for pricing.

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