Quality of Erection Study
Status and phase
Completed
Phase 4
Conditions
Erectile Dysfunction
Treatments
Drug: Sildenafil Citrate
Details and patient eligibility
About
The study objective is to evaluate the effect that sildenafil citrate has on the hardness of erections in males with erectile dysfunction, based on subject responses to question 5 on the Event Log (hardness of erection) as measured at the end of double blind treatment (week 6).
Sex
Male
Ages
18 to 55 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Male subjects aged 18-55
- 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
Trial contacts and locations
23
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Data sourced from clinicaltrials.gov
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