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

NCT05487794 | Completed DMC

• 1 other identifier: DGO-777
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Rate of Erythrocytosis

  To evaluate if the reduction of the dose of Testosterone Cypionate 200 mg to 100 mgm, biweekly, is effective to normalize the hematocrit in TM with erythrocytosis. Hemoglobin and hematocrit: will be measured by automated counting in the Biochemistry laboratory of the HCRP, using the Siemens Advia 2120i device (Siemens Healthcare GmbH®, Munich, Germany). Blood collection will be carried out in Recrututo and 3 months after intervention or control.

  3 months

Secondary Outcomes (2)

• Efects on lipids and glucose levels

  3 monsths. Blood collection will be carried out in recruitment and 3 months after intervention or control.

• Anxiety and Depression Hospital Scale (HAD)

  The scale will be applied in recruitment and 3 months after intervention or control.

Study Arms (2)

Group 1 (T100)

EXPERIMENTAL

Drug: Testosterone Cypionate 100 MG/ML

Group 1 (T0)

NO INTERVENTION

Interventions

Testosterone Cypionate 100 MG/ML 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 (T100)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Male transgender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Faculdade de Medicina de Ribeirão Preto - FMRP-USP

Ribeirão Preto, São Paulo, Brazil

Location

MeSH Terms

Conditions

Transsexualism; Hematologic Diseases

Interventions

testosterone 17 beta-cypionate

Condition Hierarchy (Ancestors)

Sexuality; Sexual Behavior; Behavior; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 4, 2022
• Study Start: September 1, 2022
• Primary Completion: November 18, 2024
• Study Completion: December 17, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

BR (1)