Health Condition 1: null- Erectile Dysfunction Health Condition 2: N528- Other male erectile dysfunction
Conditions
Interventions
Intervention1: Vardenafil Tablets: (Starting dose is 10 mg taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum recommended dose of 20 mg or decreased t
Sponsors
Ajanta Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent. 2.Patient with history, signs & symptoms of Erectile Dysfunction (Inability to attain an erection, Inability to sustain an erection, Painful erection, penile pain)
Exclusion criteria
Exclusion criteria: 1. Male < 18 years of age 2. Female 3. History of hypersensitivity to the study drug or related products. 4. Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications. 5. Patients with hypogonadism or anatomical deformities such as severe penile fibrosis. 6. Any clinical significant illness during the 4 weeks prior to day 1 of this study. 7. Participation in a clinical trial with an investigation drug within 30 days proceeding day 1 of this study. 8. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Index of Erectile Function (IIEF ?5) questionnaireTimepoint: Day 1, week 4, week 8 and week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sexual Encounter Profile (SEP) questionsTimepoint: Day 1, week 4, week 8 and week 12. | — |
Countries
India
Contacts
Public ContactDr Shailesh Singh
Ajanta Pharma Ltd, Advent
Outcome results
None listed