Testosterone replacement in men with confirmed hypogonadism and testosterone therapy for specific sexual-health indications in women are separate clinical contexts. In Australia, registered creams have distinct indications for male hypogonadism and postmenopausal hypoactive sexual desire dysfunction (HSDD). TGA registration record ↗
Men: confirmed hypogonadism
TRAVERSE enrolled symptomatic men with two low fasting testosterone results and existing or high cardiovascular risk. Gel was noninferior to placebo for major cardiovascular events; atrial fibrillation, acute kidney injury and pulmonary embolism occurred more often in the testosterone group. This does not establish safety for bodybuilding doses or all delivery methods. Source ↗
Women: sexual-health indication
APHRODITE tested a transdermal patch for low sexual desire in postmenopausal women not taking estrogen. Results cannot establish broad benefits for energy, strength or longevity. Australia’s AndroFeme cream registration is for postmenopausal HSDD. Source ↗ · Source ↗
Results are outcome-specific
The Testosterone Trials found moderate sexual-function benefit but no significant vitality benefit. The later TRAVERSE fracture substudy did not show fracture prevention and observed more clinical fractures with testosterone. Source ↗ · Source ↗
Recent research plus older foundations · Trials, observational studies and product labels are separately identified · Phases shown only when verified
2024Randomized trial substudy · TRAVERSE
More clinical fractures were observed; bone-density improvement should not be equated with fracture prevention.
Abstract / record screened; full-text, conflicts and current correction checks pending.
FOUNDATIONAL STUDY2023Phase 4 · randomized noninferiority trial
Why it matters: Major cardiovascular outcomes trial; recent and foundational.
5,246 men; transdermal gel, not injections. NCT03518034. AbbVie and other funding.
Abstract / record screened; full-text, conflicts and current correction checks pending.
FOUNDATIONAL STUDY2016Randomized placebo-controlled trials
Why it matters: Established a structured evidence base for symptomatic older men with low testosterone.
790 men aged 65 or older; sexual function, physical function and vitality outcomes. NCT00799617.
Abstract / record screened; full-text, conflicts and current correction checks pending.
2015Observational comparative study
Useful route-specific signal; not a randomized route comparison.
Abstract / record screened; full-text, conflicts and current correction checks pending.
FOUNDATIONAL STUDY2008Phase 3 · randomized trial
Why it matters: Pivotal trial in postmenopausal women not receiving estrogen.
Patch study; benefits and safety questions are specific to the studied population and exposure.
Abstract / record screened; full-text, conflicts and current correction checks pending.
2013Experimental randomized study
Mechanistic context, not a routine HRT outcomes trial.
Abstract / record screened; full-text, conflicts and current correction checks pending.