Health Condition 1: - Health Condition 2: N529- Male erectile dysfunction, unspecified Health Condition 3: N529- Male erectile dysfunction, unspecified
Conditions
Interventions
Intervention1: Sildenafil in erectile dysfunction: Tablet Sildenafil orally in licensed dose of 50-100mg on as required basis(SOS) for 12 weeks in Group-A
Control Intervention1: Tadalafil in erectile
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnosed with erectile dysfunction as per the ICD-11 criteria. 2.Participants willing to provide informed written consent for participation. 3.Participants in the age group of 21-50 years 4.Participants with adequate literacy to complete the diary card and questionnaires evaluation. 5.Participants must be staying with his spouse for a minimum period of six months and anticipate having the same adult female sexual partner during the study. 6.Participants must not have received Sildenafil or Tadalafil in the past one month.
Exclusion criteria
Exclusion criteria: 1.Participants taking organic nitrates for any reason. 2.Participants having a history of unstable angina,cardiac stents,or life threatening arrythmias. 3.Participants with a history of primary hypoactive sexual desire disorder. 4.Erectile dysfunction due to spinal cord injury. 5.Any clinical history of structural deformity causing erectile dysfunction. 6.Participants with a history of undergoing prostate surgery e.g. radical prostatectomy. 7.Participants with a clinical history of treated or untreated hypogonadism. 8.Participants with below normal serum testosterone levels. 9.Participants with a major co-morbid mental illness (i.e. schizophrenia and bipolar disorder). 10.Participants with a history of hypersensitivity or allergy to Sildenafil or Tadalafil.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess and compare the efficacy and tolerability of Sildenafil and Tadalafil in persons with erectile dysfunction.Timepoint: 0,2,4,6,8,10,12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess and compare oral Sildenafil as required versus Tadalafil as required versus Tadalafil daily dose in persons with erectile dysfunction. 2.To assess factors associated with response and non-response to treatment in erectile dysfunction. 3.To assess change in quality of life with treatment in persons with erectile dysfunction. 4.To assess change in depressive-anxiety symptoms with treatment in persons with erctile dysfunctionTimepoint: 0,2,4,6,8,10,12 weeks | — |
Countries
India
Contacts
Public ContactDr Ajeet Sidana
Government Medical College and Hospital,Sector 32,Chandigarh
Outcome results
None listed