Millions of women are being exposed to ‘best-guess’ doses of unregulated testosterone preparations for which efficacy has not been shown, experts warn.

Writing in Lancet Diabetes & Endocrinology Susan Davis and Sharon Parish from the School of Public Health and Preventive Medicine at Monash University say several roadblocks have prevented the approval of a testosterone formulation for women with loss of sexual desire or arousal.

Consequently physicians were improvising by prescribing either compounded testosterone or modified doses of approved male testosterone formulations, they said.

Unlike regulated drugs, compounded testosterone was dispensed without a requirement for inserts to explain indications, benefits, safety precautions, or risks.

Consequently, women might believe that compounded testosterone is bio-identical, and also safe if dispensed without a warning.

“A well studied testosterone formulation for women is urgently needed to protect women from inappropriate dosing when treated with testosterone formulated for men or in compounded form—which is nothing short of an unregulated human experiment,” they wrote.

To pave the way for appropriate treatment of female sexual dysfunction, recognition is needed that women are innately sexual and that female sexual dysfunction is a disorder that merits treatment, they wrote.

The international adoption of evidence based guidelines proposed by the Endocrine Society would provide clinicians with a framework for the treatment of women with testosterone, instead of the prevailing ad hoc approach, they concluded.