Effect of 100 mg of testosterone cypionate in trans men with erythrocytosis: a randomized controlled pilot study
Abstract
BACKGROUND: Testosterone cypionate is commonly administered at 200 mg every 2 weeks to facilitate masculinization in transgender men. However, this regimen may increase hematocrit (Hct) by up to 6.9%.
AIM: To compare the effects of biweekly intramuscular administration of 100 mg testosterone cypionate versus testosterone suspension on hematologic parameters and testosterone concentration in transgender men with erythrocytosis.
METHODS: A randomized, controlled pilot clinical trial which enrolled transgender men aged 18-40 years with secondary erythrocytosis (Hct ≥ 50%) related to testosterone therapy. Exclusion criteria included current contraceptive use, severe psychiatric disorders, or Hct ≥ 55%. Participants received either biweekly supervised intramuscular injections of 100 mg testosterone cypionate for 3 months or underwent complete testosterone withdrawal.
MAIN OUTCOME MEASURES: Hct, hemoglobin, and total testosterone concentrations.
RESULTS: Forty-three participants completed the study protocol. Greater reductions in Hct were observed in the control group (-3.5 ± 0.5% vs -0.8 ± 0.5%; P 1.0 percentage point reduction in Hct was expected. In the intervention group, reductions in diastolic blood pressure (117.05 ± 13.72 mmHg vs 113.19 ± 12.77 mmHg; P = .040), body weight (70.59 ± 15.16 kg vs 69.34 ± 14.44 kg; P = .003), and HADS anxiety scores (7.90 ± 4.37 vs 5.19 ± 4.17; P = 0.001) were also observed. No serious adverse events were reported.
CLINICAL IMPLICATIONS: Dose…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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