What Is a Testosterone Troche?
A troche is a small lozenge that dissolves in the mouth, releasing testosterone across the lining of the mouth — with some swallowed in saliva. It is used for prescriber-directed testosterone therapy. Testosterone is a Schedule III controlled substance and is prepared only with a valid prescription for an individual patient.
How It Works
Testosterone is the main male sex hormone and also has roles in women. A troche is held in the mouth to dissolve; however, because compounded buccal lozenges and troches result in substantial gut absorption from swallowed saliva, they are considered to act as oral testosterone therapy. Japsonline
What Is the FDA-Approved Status?
There is no FDA-approved testosterone troche. FDA-approved testosterone products for men exist in other forms (such as gels, patches, injections, and a buccal system). For women, there is no FDA-approved testosterone product of any kind. A compounded troche is therefore a non-FDA-approved, off-label preparation.
Testosterone in Women — What the Guidelines Say
The only evidence-based indication for testosterone in women is postmenopausal hypoactive sexual desire disorder (HSDD), for which transdermal testosterone is recommended; compounded products cannot be recommended because of limited efficacy and safety data. Guidance advises using government-approved male transdermal formulations at roughly one-tenth the male dose, and does not recommend injections, pellets, or oral formulations because of the potential for supraphysiologic levels. Since troches are largely swallowed, guidelines treat them as oral testosterone — a route that is not recommended for women. If no approved product is available and a compounded one is used, the compounding pharmacy should meet pharmaceutical quality standards, and dosing should be limited to the physiologic premenopausal range. ESMO Open + 3
Testosterone in Men
In men, testosterone therapy is used for diagnosed testosterone deficiency (hypogonadism), confirmed with symptoms and blood tests. A troche is one delivery form a prescriber may choose, though it is not FDA-approved. Selection, dosing, and monitoring are the prescriber's clinical decision.
Safety Information
Testosterone therapy requires monitoring. Patients should be assessed for signs of androgen excess, and testosterone levels monitored to keep them in the physiologic range. Possible effects include a rise in red blood cell count (hematocrit), acne, and — especially with higher doses in women — virilizing effects such as unwanted hair growth or voice changes, some of which may not fully reverse. Patient selection, dosing, and follow-up are the prescriber's responsibility, and Mixwell makes no recommendation about therapy. ESMO Open
Quality and Compliance — Hazardous Drug Handling
Because testosterone is a hormone handled as a hazardous drug — and a Schedule III controlled substance — Mixwell prepares troches in a purpose-built lab meeting USP <795> standards for non-sterile compounding and USP <800> standards for hazardous drugs, including HD negative-pressure containment, and dispenses only with a valid prescription for an individual patient. Mixwell is a non-sterile pharmacy and does not prepare sterile products or injectables. Compounded medications are not reviewed or approved by the FDA. Nothing here promises a specific result, and compounded preparations are not presented as superior to commercially available products.
References
- 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. doi:10.1210/jc.2019-01603.
- Parish SJ, Simon JA, Davis SR, et al. International Society for the Study of Women's Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women. J Sex Med. 2021;18(5):849–867.
- Mulhall JP, Trost LW, Brannigan RE, et al. Evaluation and Management of Testosterone Deficiency: AUA Guideline. J Urol. 2018;200(2):423–432.
- Professional Compounding Centers of America (PCCA). Formulation science and compounding resources. https://www.pccarx.com/Blog/