Effect of Dose Fractionation of Testosterone Cypionate on Transgender Men With Erythrocytosis
Status:
Not yet recruiting
Trial end date:
2025-07-31
Target enrollment:
Participant gender:
Summary
A transgender man is someone with a male identity who were born with a vulva and vagina. The
acquisition of masculine characters can come from surgery or from the use of testosterone.
Despite the benefit of using this hormone in relation to hair development, muscle mass gain
and changes in voice timbre, its use can cause an increase in the hematocrit (Ht) level. When
erythrocytosis occurs (Ht ≥ 50%), the currently proposed conduct is the suspension of
cross-hormonization for 3 months, which has negative effects on the affirmation process. This
project aims to assess whether reducing the dose of testosterone cypionate by half
(100mg/15d) can mitigate the negative outcomes caused by the suspension with the benefit of
reducing the hematocrit level in trans patients who developed erythrocytosis using
testosterone. This is a pilot study that will compare the intervention (testosterone
cypionate 100 mg, fortnightly) to the suspension of the drug, both for 3 months, with the
main outcome being the hematocrit level. Hormonal and biochemical levels and the Hospital
Anxiety and Depression scale (HAD) will also be evaluated in patients treated at the Gender
Incongruence Outpatient Clinic of the Hospital das Clínicas of the Faculty of Medicine of
Ribeirão Preto.
Phase:
N/A
Details
Lead Sponsor:
University of Sao Paulo
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo