Role Of Clomiphene Citrate In Improving Sexual Function In Hypogonadal Men: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- To study the effect of Clomiphene Citrate on Erectile Function in men with sexual dysfunction and IIEF-15 score.
研究概览
简要总结
The current study will be conducted in the IVF and Endoscopy Department, Ruby Hall clinic,
Pune. All the men attending the IVF OPD between November 2023- November 2024 with Sexual
Dysfunction will be assessed by IIEF-15 questionnaire after the detailed history. General
physical examination and local examination will be done as a part of initial workup by an
Andrologist to avoid inter-observer variability and attention will be given to note testicular size.
Hormonal profile (S.Testosterone, S.Prolactin, HbA1c) will be done. S.Testosterone, <300
ng/dl as per the cut-off for hypo-androgenism, will be followed by testing for Serum
Follicle Stimulating Hormone (S.FSH) and Serum Leutinizing Hormone (S.LH) to differentiate
between hypothalamic, pituitary or testicular dysfunction. Those with serum testosterone <
300 ng/dl and normal FSH and LH will be given a 3-month course of 25mg CC daily.
Improvement in IIEF-15 score & S.Testosterone will be assessed at 6weeks and 3 months of drug intake
and the data will be recorded in a preset format.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Male
入选标准
- •Hypogonadal men with Sexual Dysfunction Age 18-75 years Willing to be a part of the study Serum Testosterone level <300ng/dl Serum LH between 1.2 -8 IU/L.
排除标准
- •Hyperprolactinaemia Diabetes Mellitus Age <18 or >75 years Not willing to be a part of the study Baseline Serum Testosterone ≥300 ng/dL Men with Hypergonadotropic Hypogonadism (FSH >8IU/L, LH >8IU/L) Men with Hypogonadotropic Hypogonadism (FSH <1.2 IU/L, LH <1.2IU/L) CC allergy.
结局指标
主要结局
To study the effect of Clomiphene Citrate on Erectile Function in men with sexual dysfunction and IIEF-15 score.
时间窗: At baseline, 4weeks and 8weeks
次要结局
- Improvement in Serum Total Testosterone level.(To study the effect of Clomiphene Citrate on orgasmic function.)
研究者
Dr Tejas Gundewar
Ruby Hall Clinic