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Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations

CHANGE OF CITRATE FROM SILDENAFIL TO TADALAFIL IN THE TREATMENT OF ERECTIL DISSIPATION: MULTINATIONAL EVALUATION OF PREFERENCE OF THE TREATMENT

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
REPEC
Registry ID
PER-002-03
Enrollment
31
Registered
2003-02-27
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

Tadalafil 20 mg Type of group
Tadalafil 20mg was given after having been treated with Sildenafil Citrate for at least ten (10) weeks.

Sponsors

ELI LILLY INTERAMERICA INC.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) were male and at least 18 years of age; 2) have signed informed consent; 3) had a history of DE for at least 3 months; 4) were users of sildenafil at a stable dose for 6 weeks or more; 5) having anticipated having the same sexual partner during the study to record the answers to the efficacy questionnaires; 6) to have agreed not to use any other treatment for ED throughout the study except study medication.

Exclusion criteria

Exclusion criteria: Presenting impotence caused by other primary sexual disorders including premature ejaculation or impotence caused by an untreated endocrine disease. Have a history of radical prostatectomy Have a history of a penile implant. Having a clinically significant deformity in the penis in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
Outcome name:Disposition of the patient and his reason Measure:Patient choice of treatment (either sildenafil or tadalafil) for use in the extension phase Timepoints:14 weeks

Secondary

MeasureTime frame
Outcome name:PAIRS scale Measure:Assessment of sexual encounter attributes measured by the PAIRS scale including the Sexual Self-Confidence, Romance, and Time Pressure domains. Timepoints:26 weeks

Countries

Austria, Brazil, Chile, Colombia, Costa Rica, Czech Republic, Israel, Malasya, Mexico, New Zealand, Peru, Philippines, Poland, Puerto Rico, Russian Federation, Singapore, Slovakia, Taiwan, Turkey, Venezuela

Outcome results

None listed

Source: REPEC (via WHO ICTRP)