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

NCT ID: NCT05487794

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-12-17

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1 (T100)

Group Type: EXPERIMENTAL

Testosterone Cypionate 100 MG/ML

Intervention Type: DRUG

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).

Group 1 (T0)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• TM aged between 18 and 40 years in threatmeant with Testosterone Cypionate 200mg/2mL with a diagnosis of erythrocytosis (Ht⩾50%).

Exclusion Criteria

• TM with polycythemia vera or secondary to other pathologies (chronic kidney disease, severe lung disease, chronic myeloid leukemia, lymphoma, liver diseases and Cushing's syndrome);
• TM in use of hormonal contraceptives or copper IUDs;
• TM with psychiatric conditions such as severe psychotic disorders, severe personality disorders
• Patients with Ht > 54.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

SERGIO HENRIQUE PIRES OKANO

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculdade de Medicina de Ribeirão Preto - FMRP-USP

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

Other Identifiers

DGO-777

Identifier Type: -

Identifier Source: org_study_id