Role of Testosterone and Its Metabolites Regarding Different Physiological Functions in Subjects Affected by Gender Identity Disorder (FtM Transsexuals)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- lipid profile
研究概览
简要总结
The purposes of this study are:
- to determine the role of testosterone versus dihydrotestosterone with respect to the following physiological functions: bone metabolism, body composition, insulin resistance and lipid profile
- to determine the role of testosterone and dihydrotestosterone versus estradiol with respect to the following physiological functions: bone metabolism, body composition, insulin resistance and lipid profile
详细描述
BACKGROUND GID is a psychic disorder in which an otherwise normal person feels like he/she is a member of the opposite sex to which she/he belongs biologically. These patients require hormonal treatment to suppress the somatic characteristics of their own sex and to develop the somatic characteristics of the other sex. After psychotherapy and a period of hormonal treatment, they undergo surgical sex reassignment which, in the case of FtM subjects, consists of hystero-adnexectomy, reductive mastoplasty and possibly penile reconstruction. Thereafter, and for their entire life, they must be treated with testosterone (T) to maintain androgen-dependent physiological functions.
RATIONALE After sex-reassignment surgery, FtM subjects must be treated with T for their entire life in order to maintain androgen-estrogen dependent physiological functions.
These subjects represent an interesting model for the study of the effects of testosterone and its metabolites on different physiological functions. As of now, there is no information that the androgen receptors differ in males and females. Therefore, induction of the androgen effects in the FtM subjects can be considered similar to those in hypogonadal men and FtM subjects can serve as a model of the hypogonadal male.
Therefore, the aim of this trial is to evaluate the effects of selective steroid replacement on different physiological functions. In particular in this study we will evaluate the relative role of testosterone, DHT and estradiol on the different physiological functions. For these purposes, we will administer testosterone undecanoate alone (Group A) or in combination with letrozole, an aromatase inhibitor (Group B). A third group of FtM subjects will be treated with TU plus dutasteride (Group C).
In view of the development of selective androgen receptor modulators, the understanding of the relative role of each steroid on different physiological functions will provide useful information for future therapeutic indications. The information collected in this study will greatly help to optimize the long-term treatment of FtM subjects.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy biological females, between 18 and 45 years of age:
- •SR surgery performed
- •Body Mass Index (BMI) between 20 and 29 kg/m²; (body weight in kilograms divided by body height in meters squared)
- •Clinical examination without pathological findings relevant to the study
- •Clinico-chemical laboratory values do not suggest an illness
- •Written Consent Form has been signed
- •High probability of a good compliance and termination of the study
排除标准
- •Subjects cannot be enrolled in this study if one or more of the following criteria apply:
- •Participation in another clinical trial within the 30 days preceding the first administration
- •Simultaneous participation in another clinical trial
- •Subjects institutionalized or imprisoned by order of the court
- •Subject who compete in sports which use IOC drug monitoring
- •Serious organic or psychic disease suspected from history and/or clinical examination
- •Diseases (especially tumors) that might represent an actual contraindication for testosterone
- •Past or present history of thrombotic or embolic diseases
- •Hypertension requiring therapy (BP 140/90 mmHg)
- •Diabetes mellitus requiring therapy
- •Acute or chronic hepatic diseases
- •Manifest renal diseases with renal dysfunction
- •Severe internal diseases as well as use of any medication to treat such
- •Biochemical and/or hematological laboratory values beyond normal ranges unless the Investigator confirms that the deviations are of no clinical relevance
- •Any indication of chronic use of drugs, alcohol, opiates or recreational drugs
- •Use of any drug known to affect biotransformation of testosterone and/or progestin, e.g. chlorcycline, phenobarbital, phenylbutazone, aminophenazone within the 30 days preceding the first administration of the test medication and during the study
- •Use of oral anticoagulatory drugs within the 30 days preceding the first administration of the test medication and during the study
- •Any oral or transdermal hormone medication within the 12 weeks preceding the first administration and during the study
- •Probability of poor compliance and termination of the study
结局指标
主要结局
lipid profile
时间窗: baseline and end of the study
bone metabolism
时间窗: baseline and end of the study
insulin resistance
时间窗: baseline and end of the study
次要结局
- sexual function(baseline and end of the study)
- mood(baseline and end of the study)
- pain(baseline and end of the study)