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临床试验/NCT05487794
NCT05487794已完成不适用

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

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Rate of Erythrocytosis

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Group 1 (T100)

Experimental

干预措施: Testosterone Cypionate 100 MG/ML (Drug)

结局指标

主要结局

Rate of Erythrocytosis

时间窗: 3 months

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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

SERGIO HENRIQUE PIRES OKANO

Principal investigator

University of Sao Paulo

研究点 (1)

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