Effects of Three Different Medications on Metabolic Parameters and Testicular Volume in Patients With Hypogonadotropic Hypogonadism-Last Three Years Experience
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Effects of testosterone enanthate and testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.
研究概览
简要总结
The aim of the present study was to demonstrate the influences of three different treatment strategies on biochemical parameters and testicular volume (TV) in patients with idiopathic hypogonadotropic hypogonadism (IHH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •hypogonadotropic hypogonadism
- •decreased serum testosterone concentration below the normal range (serum T < 300ng/dL),
- •FSH and LH levels within or below the normal range,
- •absence of a pituitary or hypothalamic mass lesions on MRI, presence of gonadotropin response to repetitive doses of GnRH,
- •normal smell test and normal karyotypes
排除标准
- •previous androgen treatment,
- •history of smoking,
- •presence of bilateral anorchia,
- •intellectual deficiency,
- •diabetes mellitus,
- •arterial hypertension or dyslipoproteinemia,
- •medication of any kind and drug abuse. Because of possible confounding effects, patients with other hormone deficiencies were excluded.
- •Participants with iron, vitamin B12 or folate deficiency were also excluded.
研究组 & 干预措施
hypogonadism, treatment
77 patients with idiopathic hypogonadotropic hypogonadism were treated with testosterone gel, testosterone enanthate or human chorionic gonadotropin
干预措施: Testosterone enanthate (Sustanon 250 mg) (Drug)
hypogonadism, treatment
77 patients with idiopathic hypogonadotropic hypogonadism were treated with testosterone gel, testosterone enanthate or human chorionic gonadotropin
干预措施: Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU) (Drug)
hypogonadism, treatment
77 patients with idiopathic hypogonadotropic hypogonadism were treated with testosterone gel, testosterone enanthate or human chorionic gonadotropin
干预措施: Testosteron gel (Testojel 50 mg) (Drug)
Control group
42 healthy controls
干预措施: Testosterone enanthate (Sustanon 250 mg) (Drug)
结局指标
主要结局
Effects of testosterone enanthate and testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.
时间窗: 3 years
Effects of testosterone gel on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.
时间窗: 3 years
Effects of human chorionic gonadotrophin on BMI, haemoglobin, haematocrit, urea creatinine, triglyceride, total testosterone (TT) and HDL-cholesterol were measured.
时间窗: 3 years
次要结局
- Effect of testosterone gel on testis volumes(3 years)
- Effect of human chorionic gonadotrophin on testis volumes(3 years)
- Effect of testosterone enanthate on testis volumes(3 years)
研究者
Aydogan Aydogdu
Principal Investigator
Gulhane School of Medicine