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Effect of dose fractionation of Testosterone on red blood cells in Transgender Men

Effect of dose fractionation of Testosterone Cypionete on hematocrit in Transgender Men with Erythrocytosis secondary to testosterone use

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-479v8tv
Enrollment
Unknown
Registered
2022-10-27
Start date
2022-09-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transsexualism

Interventions

The study is presented as a randomized pilot study blinded to the researcher and statistician. A total of 40 people can be used to allow another intervention group to be used and be a computer generat
while group 2 (T0): participant will discontinue the use of testosterone due to erythrocytosis. Data collection and application of questionaires will occur 11 week after recruitmeant. Pre and post-int
D06.472.334.851.968.984

Sponsors

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Transgender men with and with a diagnosis of testosterone-induced erythrocytosis will be included.

Exclusion criteria

Exclusion criteria: Male transgender (MT) with polycythemia vera or secondary to other pathologies (chronic kidney disease, severe lung disease, chronic myeloid leukemia, lymphoma, liver diseases and Cushing's syndrome); MT using hormonal contraceptives or copper IUDs; MT with psychiatric conditions such as severe psychotic disorders, severe personality disorders.

Design outcomes

Primary

MeasureTime frame
It is expected to find hematocrit reduction to less than 50% with dose reduction for 3 months in these patients.

Secondary

MeasureTime frame
It is expected to find a more favorable bleeding pattern (amenorrhea or infrequent) with fractional dose prescription compared to drug withdrawal at 3 months.;It is expected to find an anxiety and depression score with fractional dose prescription compared to drug withdrawal at 3 months.;It is expected to find maintenance of normal hormones with fractional dose prescription compared to drug withdrawal at 3 months.;It is expected that no biochemical alterations will be found between the MDs who used the fractionated dose and those who discontinued the use of testosterone cypionate during the three months of intervention.

Countries

Brazil

Contacts

Public ContactSergio Pires Okano

Faculdade de Medicina de Ribeirão Preto

sergio.okano@usp.br+55 (16) 996136856

Outcome results

None listed

Source: REBEC (via WHO ICTRP)