Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction

Viatris

Status and phase: Completed; Phase 4

Conditions: Impotence

Treatments: Drug: Sildenafil Citrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00245258

A1481239

Details and patient eligibility

About

The study objective is to:

1. To evaluate the effect of sildenafil citrate versus placebo on the IIEF_EF Domain at the end of the double-blind phase
2. To assess the relationship between treatment with sildenafil citrate or placebo and responses to the Quality of Erection Questionnaire (QEQ) and Sexual Experience Questionnaire (SEX_Q).

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male subjects aged 18-65.
• Documented clinical diagnosis of erectile dysfunction confirmed by an IIEF-EF Domain score of less than or equal to 25. (If the subject scores greater than 25 on the IIEF-EF Domain, screening procedures should be terminated.)

Exclusion criteria

• Subjects who have been treated with more than 6 doses of sildenafil citrate or any other phosphodiesterase type 5 (PDE-5) inhibitor such as vardenafil or tadalafil for erectile dysfunction [Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening].

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind