FindTrial
Sign In

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.

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.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
REPEC
Registry ID
PER-092-03
Enrollment
Unknown
Registered
2003-12-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Vardenafil Type of group
Vardenafil 10 mg (Levitra®) will be given as tablets for 4 weeks. Subjects should take a tablet of vardenafil one hour before the scheduled sexual intercourse. Group name:Tadalafil Type of group
tadalafil 10 mg (Cialis®) will be given as tablets for 4 weeks. Subjects should take a tablet of vardenafil one hour before the scheduled sexual intercourse.

Sponsors

BAYER S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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. 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. Timepoints:4 weeks—

Secondary

MeasureTime frame
Outcome name:Was he able to insert his penis into his partner´s vagina? Measure:Ability to introduce the penis according to the answer in the diary of the subject to question 2 of the Sexual Act Profile. Timepoints:4 weeks—

Countries

Japan, Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)