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临床试验/CTRI/2021/10/037629
CTRI/2021/10/037629尚未招募未知

Effect of Tadalfil on Erectile Dysfunction among North Indian Males with Diabetes Mellitus-A Randomized Controlled Trial.

GSVM Medical College0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • a. 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

研究者

发起方
GSVM Medical College

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