An interventional study of Testosterone Cypionate 100 MG/ML in Testosterone, Transsexualism and Hematologic Diseases, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment
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.
609 studies on the registry are indexed under Hematologic Diseases; 108 are open to participants now.
This study's enrollment of 46 is close to the median of 50 across 410 interventional studies indexed under Hematologic Diseases.
Browse Hematologic Diseases studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Hematologic Diseases, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Transsexualism. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Testosterone Cypionate 100 MG/ML
Drug page: Testosterone 17 beta-cypionate
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).
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.
Time frame: 3 months
Efects on lipids and glucose levels
Blood samples will be collected between seven and eight in the morning, after a minimum of twelve hours fasting. In each evaluation, 20 mL of whole blood will be collected and stored in conical plastic tubes (BD-Becton Dickinson, Plymouth, United Kingdom) with a vacuum and a separating gel barrier. It will be measured: total cholesterol (TC), HDL-cholesterol and triglycerides (TG) by enzymatic method in the Biochemistry laboratory of HCRP. The device used will be the Siemens Atellica CH 930 (Siemens Healthcare GmbH®, Munich, Germany). LDL-cholesterol will be calculated from the Friedewald formula, if there is no dosage of TG greater than 400mg/dL (Friedewald et al., 1972). Fasting blood glucose will be determined by the enzymatic method in the Biochemistry laboratory of the HCRP and the device used will be the Siemens Atellica CH 930 (Siemens Healthcare GmbH®, Munich, Germany)
Time frame: 3 monsths. Blood collection will be carried out in recruitment and 3 months after intervention or control.
Anxiety and Depression Hospital Scale (HAD)
To evaluate the emotional state regarding the presence of anxiety and depression, the Brazilian version of the Hospital Anxiety and Depression Scale (HAD) will be used, which consists of 14 questions that assess some aspects of mood and behavior (Appendix 4). Scores ≥ 9 in the questions corresponding to anxiety or depression characterizes the psychic state of the woman.Zigmond \& Snaith, 1983).
Time frame: The scale will be applied in recruitment and 3 months after intervention or control.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Sep 2022 to primary completion in Nov 2024, 26 months.
Of 51 non-industry interventional studies with no phase under Hematologic Diseases, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 49. This study's 26 months is below that.
Counting every sponsor, half of 54 studies reached it within 37 months; a quarter within 22 and three quarters within 47.
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Testosterone 17 beta-cypionate