ISRCTN15726488已完成Unknown
Sublingual estradiol alone versus oral estradiol with cyproterone acetate (CPA) for the initial treatment of transgender women seeking gender-affirming-hormonal-therapy (GAHT)- A prospective pilot study at the Transgender Health Clinic of the Institute of Endocrinology at Tel Aviv Sourasky Medical Center
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Testosterone concentration measured using an electro-chemiluminescence assay (COBAS 6000, e 691 modules,113 Roche, Switzerland), at baseline before treatment, and at the end of the study after 6 months of treatment
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38130980/ (added 13/09/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •Treatment-naive transgender women aged 18 years and older seeking gender-affirming therapy (GAHT), at the Transgender Health Center Clinic within the Institute of Endocrinology and Metabolism at Tel Aviv-Sourasky Medical Center
- •Willing to participate in the study
- •Mentally capable of giving informed consent
排除标准
- •A history of chronic liver or kidney disease, GFR=60 ml/min
- •Hypertriglyceridemia>300 mg/dl
- •Primary hypogonadism as evidenced by below-normal serum testosterone and elevated gonadotropins
- •A history of malignancy in the preceding 5 years
- •Use of CYP3A4 inducers (phenytoin, rifampin) or inhibitors (ketoconazole, clotrimazole or retroviral drugs such as ritonavir)
- •Drug or alcohol abuse
- •Previous history of suicide attempt
结局指标
主要结局
Testosterone concentration measured using an electro-chemiluminescence assay (COBAS 6000, e 691 modules,113 Roche, Switzerland), at baseline before treatment, and at the end of the study after 6 months of treatment
次要结局
- The following secondary outcome measures were assessed at baseline and after 6 months unless stated:1. Gender dysphoria measured using the Gender Dysphoria and Life Satisfaction (GCLS) questionnaire2. Libido measured using the Sexual Desire Inventory (SDI) questionnaire3. Sexual function measured using the International Index of Erectile Function (IIEF) questionnaire4. Safety measures consisted of an array of biochemical (on an Advia Centaur XP autoanalyzer, Siemens, 110 Germany), hematological (on a Beckman Coulter Counter, IN, USA), and hormonal laboratory (on the Immulite® 2000, Siemens, Germany) variables, drawn at baseline, 3 months, and 6 months5. Body composition measured using DXA (Lunar Prodigy system, GE Healthcare, Chicago, IL), and by BIA (InBody 770 body composition analyzer, InBody Co., Ltd, Seoul, Korea) at baseline and 6 months
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