Effect of Tadalfil on Erectile Dysfunction among North Indian Males with Diabetes Mellitus.
- Conditions
- Health Condition 1: E106- Type 1 diabetes mellitus with other specified complicationsHealth Condition 2: E116- Type 2 diabetes mellitus with other specified complications
- Registration Number
- CTRI/2021/10/037629
- Lead Sponsor
- GSVM Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method