NCT05487794

Effect of Dose Fractionation of Testosterone Cypionate on Transgender Men with Erythrocytosis

Effect of Dose Fractionation of Testosterone Cypionate on Hematocrit in Transgender Men with Erythrocytosis Secondary to Testosterone Use.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Testosterone
• Transsexualism
• Hematologic Diseases

Interventions

Type	Name	Description
DRUG	Testosterone Cypionate 100 MG/ML	Testosterone is also responsible for increasing hematocrit by stimulating erythropoiesis (Velho et al., 2017). In cisgender men, who are hypogonadal and do not adequately produce testosterone, treatment with the use of testosterone is associated with stimulation of erythropoiesis, which can potentially increase blood viscosity, resulting in secondary erythrocytosis (Hajjar et al., 1997).

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-11-18
• Completion: 2024-12-17
• First posted: 2022-08-04
• Last updated: 2025-03-28

Locations

1 site across 1 country: Brazil