Long-term gender-affirming hormone therapy for trans men is safe and effective, and low-dose testosterone administration is sufficient to increase lean body mass, though higher doses lead to an earlier increase in muscle mass.
Key Findings
Results
Both low-dose and high-dose testosterone groups showed decreases in body fat percentage and increases in lean body mass during the first year of therapy, followed by a slight increase in both over the long term.
Low-dose group was defined as ≤62.5 mg/wk and high-dose group as >62.5 mg/wk of testosterone
Of 291 participants, 188 patients (64.6%) were in the low-dose group and 103 (35.4%) in the high-dose group
Both groups demonstrated the same directional changes in body fat percentage and lean body mass during the first year
After the first year, both body fat percentage and lean body mass showed a slight increase over the long term in both groups
Results
The high-dose testosterone group exhibited greater lean body mass gains during the first year of therapy compared to the low-dose group.
Higher hormone doses were associated with lean body mass increases at 3 months (P = 0.006) and 6 months (P = 0.015)
Lower initial lean body mass values were also associated with lean body mass increases at 3 months (P < 0.001) and 6 months (P < 0.001)
The difference in lean body mass gains between groups was most pronounced during the first year of treatment
Despite greater early gains, the low-dose group still achieved adequate muscular development over the long term
Results
Cumulative menstrual cessation rates up to 12 months were not significantly different between the low-dose and high-dose testosterone groups.
Menstrual cessation was one of the recorded physical findings alongside body mass index, body fat percentage, lean body mass, and grip strength
No statistically significant difference was found between groups in cumulative menstrual cessation rates within the first 12 months
The study period for participant initiation of gender-affirming hormone therapy spanned from May 2000 to December 2021
Results
There were no long-term, dose-dependent side effects such as polycythemia or dyslipidemia observed in either testosterone dose group.
Blood testing results monitored included hemoglobin, hematocrit, uric acid, creatinine, total cholesterol, triglycerides, and total testosterone
Polycythemia and dyslipidemia were specifically assessed as potential adverse effects of testosterone therapy
No dose-dependent relationship was found for these safety parameters over the long-term follow-up period
The study was a retrospective analysis spanning participants who initiated therapy between May 2000 and December 2021
Results
Low-dose testosterone administration (≤62.5 mg/wk) is sufficient to increase lean body mass in trans men.
The majority of the study cohort (188 of 291 patients, 64.6%) were in the low-dose group
Low-dose group still demonstrated measurable increases in lean body mass, particularly during the first year
The authors concluded that while higher doses lead to earlier muscle mass increases, low-dose therapy achieves adequate muscular development
This finding supports the use of lower testosterone doses as an effective option for gender-affirming hormone therapy in trans men
Background
Few long-term studies on the safety and efficacy of gender-affirming hormone therapy were available prior to this study.
The paper identifies a gap in the literature regarding long-term safety and efficacy data for testosterone therapy in trans men
The study was designed specifically to investigate long-term physical effects and safety of testosterone therapy
The retrospective analysis included 291 trans men who initiated gender-affirming hormone therapy over a 21-year period (May 2000 to December 2021)
Tominaga Y, Kobayashi T, Matsumoto Y, Moriwake T, Oshima Y, Okumura M, et al.. (2025). Trans men can achieve adequate muscular development through low-dose testosterone therapy: A long-term study on body composition changes.. Andrology. https://doi.org/10.1111/andr.13640