A clinical Trial in Men with Erectile Dysfunction. Clinical trial is to study efficacy, safety and tolerability of Vardenafil Tablets in comparison to Tadalafil Tablets (reference product).
- Conditions
- Health Condition 1: null- Erectile DysfunctionHealth Condition 2: N528- Other male erectile dysfunction
- Registration Number
- CTRI/2010/091/001268
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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)
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method International Index of Erectile Function (IIEF ?5) questionnaireTimepoint: Day 1, week 4, week 8 and week 12.
- Secondary Outcome Measures
Name Time Method Sexual Encounter Profile (SEP) questionsTimepoint: Day 1, week 4, week 8 and week 12.