A RANDOMIZED, OPEN, MULTICENTER STUDY IN PARALLEL GROUPS TO DETERMINE THE EFFICACY AND SAFETY OF VARDENAFILO (10 MG, TAKEN ONE HOUR BEFORE SEXUAL ACTIVITY) COMPARED WITH TADALAFILO (10 MG 24 HOURS BEFORE THE SEXUAL ACTIVITY) IN VARONENES WITH ERECTILE DYSFUNCTION AND DIABETES MELLITUS AND / OR HYPERTENSION AND / OR HYPERLIPIDEMIA.
Phase 1
- Conditions
- -F52F52
- Registration Number
- PER-092-03
- Lead Sponsor
- BAYER S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Heterosexual relationship.
Older than 18 years.
Men with erectile dysfunction for more than six months.
The subject must perform at least four attempts at sexual intercourse.
Informed consent documented in writing.
Exclusion Criteria
Subjects that during the study do not wish to abandon the use of devices
vacuum, intracavernous injections, Viagra® or other treatments for
erectile dysfunction.
Known hypersensitivity to vardenafil.
Subjects who do not wish or are unable to complete the subject´s diary.
Subjects illiterate or who do not understand the language in which the questionnaires or the diary of the subject are written.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Number of attempts (satisfactory / unsatisfactory) according to the answers to question 3 of the Sexual Act Profile: Did your erection remain long enough to allow you to perform a successful sexual intercourse? observed during 15 min-4 h and during 22-26 h. in the vardenafil and tadalafil groups, respectively.<br>Measure:Efficacy and safety of vardenafil, an inhibitor of phosphodiesterase type 5, at a concentration of 10 mg, compared to those of tadalafil, an inhibitor of phosphodiesterase type 5, at a concentration of 10 mg in men with erectile dysfunction.<br>Timepoints:4 weeks<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Was he able to insert his penis into his partner´s vagina?<br>Measure:Ability to introduce the penis according to the answer in the diary of the subject to question 2 of the Sexual Act Profile.<br>Timepoints:4 weeks<br>