Effect of Tadalfil on Erectile Dysfunction among North Indian Males with Diabetes Mellitus-A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- a.Efficacy -
研究概览
简要总结
Erectile dysfunction (ED) is a common comorbidity in patients with diabetes. As many as 60- 75% of diabetic men will experience at some time in their lives with a consistent or recurrent inability to achieve and maintain an erection adequate for sexual performance. Ed is observed as normal aging process also, however diabetic patients encounter ED typically at an earlier age than their counterparts with normal glycemic control. Not only does diabetes increase the risk of ED nearly twofold, but ED may also be the first symptom of diabetes and may significantly predict of neuropathic symptoms and poor glycemic control. It is also associated with lowered confidence and self respect. Although improvement in erectile function (EF) is paramount in the treatment of erectile dysfunction (ED), the impact of the disease is multifaceted, and includes a myriad of physical and psychosocial aspects not addressed by improvement of EF alone. In fact, one of the first concerns of men who choose to undergo treatment is for their partner’s sexual satisfaction. Tadalafil, a potent, selective and reversible inhibitor of phosphodiesterase type 5 has been approved as an oral therapy for erectile dysfunction. Tadalafil has a time to maximum concentration of 2 h and a half-life of 17·5 h. The efficacy of tadalafil taken once daily, its impact on men’s sexual satisfaction, confidence and self-esteem, or their female partner’s satisfaction, has not yet been much among North Indian population. Therefore this trial aims at finding efficacy, safety of Tadalafil in North Indian subjects suffering from T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •Men aged 18 years to 60 years both inclusive with a clinical diagnosis of type 1 or type 2 diabetes, a minimum 3-month history of mild-to-severe ED, and a stable monogamous relationship with a female partner will be eligible b.A clinical diagnosis of diabetes was predicated on either current therapy with insulin, metformin, or sulfonylureas or a history within the previous year of two occasions of diagnostic-level hyperglycemia, including 1) fasting plasma, serum, or blood glucose 126 mg/dl; 2) randomly obtained plasma, serum, or blood glucose 200 mg/dl) associated with symptoms of polyuria, polydipsia, or unexplained weight loss; or 3) plasma, serum, or blood glucose 200 mg/dl) 2 h after administration of 75 g oral glucose.
- •c.Any patient with an onset of diabetes before the age of 30 years who had received continuous insulin treatment since diagnosis will be considered to have type 1diabetes.
- •d.Men with a history of hypertension and hypercholesterolemia will be included.
- •e.Patients will be eligible for study inclusion irrespective of previous responses to ED treatments, including sildenafil.
- •f.men with micro-vascular complications, including retinopathy, will remain eligible g.Anticipate having same adult female sexual partner during the study.
- •h.Agree to make at least 2 sexual intercourse attempts with the female partner during the 2 week run-in phase without medication.
- •i.Agree to make at least 1 sexual intercourse attempt per day with the female partner during days 1-4 following randomization (with a minimum of two attempts required during that period).
- •Also agree to make at least 3 intercourse attempts during days 5-14 following randomization.
- •j.Agree not to use any other ED treatment during the study and for 24 hours after the final study visit.
排除标准
- 未提供
结局指标
主要结局
a.Efficacy -
时间窗: a.Efficacy - | i.IIEF - The effects of tadalafil on erectile function were evaluated using the International Index of Erectile Function (IIEF), a 15-item questionnaire that assesses five domains of male sexual function using 5- to 6-point Likert scales, with 0 or 1 signifying a low frequency or ability and 5 signifying a high frequency or ability. These domains include erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. | ii.Patients also used Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) diaries to record their sexual experiences. The treatment satisfaction will be measured by the EDITS index
i.IIEF - The effects of tadalafil on erectile function were evaluated using the International Index of Erectile Function (IIEF), a 15-item questionnaire that assesses five domains of male sexual function using 5- to 6-point Likert scales, with 0 or 1 signifying a low frequency or ability and 5 signifying a high frequency or ability. These domains include erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction.
时间窗: a.Efficacy - | i.IIEF - The effects of tadalafil on erectile function were evaluated using the International Index of Erectile Function (IIEF), a 15-item questionnaire that assesses five domains of male sexual function using 5- to 6-point Likert scales, with 0 or 1 signifying a low frequency or ability and 5 signifying a high frequency or ability. These domains include erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. | ii.Patients also used Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) diaries to record their sexual experiences. The treatment satisfaction will be measured by the EDITS index
ii.Patients also used Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) diaries to record their sexual experiences. The treatment satisfaction will be measured by the EDITS index
时间窗: a.Efficacy - | i.IIEF - The effects of tadalafil on erectile function were evaluated using the International Index of Erectile Function (IIEF), a 15-item questionnaire that assesses five domains of male sexual function using 5- to 6-point Likert scales, with 0 or 1 signifying a low frequency or ability and 5 signifying a high frequency or ability. These domains include erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. | ii.Patients also used Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) diaries to record their sexual experiences. The treatment satisfaction will be measured by the EDITS index
次要结局
- a.Included the changes from baseline to end point in mean scores on IIEF-Q3 (penetration ability) and IIEF-Q4 (maintenance ability) in each treatment group.(b.Proportions of patients achieving more than a five-point gain from baseline to end point in the erectile function domain of the IIEF were also determined for all treatment groups.)