A Randomized Double-blind Placebo-controlled Pilot Trial on the Effects of Testosterone Undecanoate Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolic Profile in Transmen
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 主要终点
- Change in body composition
研究概览
简要总结
To compare the effects on body composition and muscle strengthof 54-weeks treatment with of testosterone undecanoate combined with placebo or with the 5a-reductase inhibitor dutasteride
详细描述
Transmen who have undergone gender-affirming surgery require long-lasting treatments with androgens to maintain male phenotypic characteristics and to preserve their health. In this population the effects on muscle and the relative role of testosterone and its metabolite dihydrotestosterone (DHT) on the skeletal muscle are still largely unknown.
In this pilot study, we evaluated the effects of testosterone and DHT on muscle strength, body composition, metabolism. Also cutaneous androgenic effects such as acne and androgenetic alopecia were evaluated.
DESIGN
For this purpose, in this randomized, double-blind placebo-controlled pilot trial we treated variectomized transmen for 54 weeks with:
- Testosterone Undecanoate (TU) 1000 mg i.m. at weeks zero, six, 18, 30, 42 + a daily oral placebo pill (TU+PL)
- TU 1000 mg i.m. at weeks zero, six, 18, 30, 42 + dutasteride 5 mg/day (TU+DUT).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Only the research pharmacist was aware of the randomization results.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy transmen
- •Previous bilateral gonadectomy during sex reassigning surgery
- •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
- •No concomitant use of drugs known to affect the hypothalamic-pituitary-ovarian axis
- •Written Consent Form
- •High probability of a good compliance and termination of the study
排除标准
- •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
- •Subjects reporting desire to perform regular physical exercises for the duration of the study
- •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
- •Arterial hypertension
- •Diabetes mellitus
- •Acute or chronic hepatic diseases
- •Manifest renal diseases with renal dysfunction
- •Severe internal diseases
- •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
研究组 & 干预措施
Testosterone Undecanoate plus dutasteride
Testosterone Undecanoate (TU) 1000 mg i.m. at weeks zero, six, 18, 30, 42 + dutasteride 5 mg/day
干预措施: dutasteride 5 mg/day (Drug)
Testosterone Undecanoate plus dutasteride
Testosterone Undecanoate (TU) 1000 mg i.m. at weeks zero, six, 18, 30, 42 + dutasteride 5 mg/day
干预措施: Testosterone Undecanoate (Drug)
Testosterone Undecanoate plus placebo
Testosterone Undecanoate (TU) 1000 mg i.m. at weeks zero, six, 18, 30, 42 + a daily oral placebo pill
干预措施: Testosterone Undecanoate (Drug)
结局指标
主要结局
Change in body composition
时间窗: At baseline and after 54 weeks of treatment
Dual-energy X-ray absorptiometry was performed using the Hologic 49159 densitometer and standard QDR body composition software (Model QDR4500W, Software Level 11.2, Hologic Spine; Hologic, Bedford, MA) for the measurement of body fat and lean mass
Change in handgrip strength
时间窗: At baseline and after 54 weeks of treatment
Three trials of three sets of maximal isometric handgrip on a mechanical dynamometer (model Grip-A, Takei Physical Fitness Test TKK 5001, Japan), alternately with the dominant and non-dominant hand, with a three minute rest between each trial
Change in anthropometric assessment: waist-to-hip ratio
时间窗: At baseline and after 54 weeks of treatment
Waist and hip circumferences will be combined to report the waist-to-hip ratio (WHR)
Change in isokinetic knee extension and flexion peak torque (PT-IKE and PT-IKF)
时间窗: At baseline and after 54 weeks of treatment
Isokinetic peak torques were determined using isokinetic dynamometry (Biodex System 4 Pro, Medical Systems, Shirley, NY) at all four time points.
Change in bone mineral density
时间窗: At baseline and after 54 weeks of treatment
Dual-energy X-ray absorptiometry was performed using the Hologic 49159 densitometer and standard QDR body composition software (Model QDR4500W, Software Level 11.2, Hologic Spine; Hologic, Bedford, MA) for the evaluation of bone mineral density at lumbar and femoral site
Change in anthropometric assessment: BMI
时间窗: At baseline and after 54 weeks of treatment
weight, stature will be combined to report the BMI (kg/m\^2)
次要结局
- Change in in the bone metabolism: parathyroid hormone(At baseline and after 54 weeks of treatment)
- Change in in the bone metabolism: urinary excretion of electrolites(At baseline and after 54 weeks of treatment)
- Change in the satisfaction with their sexual life(At baseline and after 54 weeks of treatment)
- Change in in the bone metabolism: osteocalcin(At baseline and after 54 weeks of treatment)
- Change in in the bone metabolism: bone alkaline phosphatase(At baseline and after 54 weeks of treatment)
- Change in in the insulin resistance(At baseline and after 54 weeks of treatment)
- Change in psychological profile with the brief Profile of Mood State (POMS)(At baseline and after 54 weeks of treatment)
- Change in the lipid profile(At baseline and after 54 weeks of treatment)
研究者
maria cristina meriggiola
Principal Investigator
Unita Complessa di Ostetricia e Ginecologia