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Do patients’ baseline characteristics with erectile dysfunction, predict phosphodiesterase type 5 (PDE5) inhibitors’ efficacy and patients’ preference? A comparative, randomized, open-label, crossover study.

To identify the parameters of a patient with specific social status and unique medical history, which can influence the reply to the phosphodiesterase type 5 (PDE 5) inhibitors due to erectile dysfunction.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000921280
Enrollment
200
Registered
2009-10-27
Start date
2004-06-22
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

To compare the efficacy and the side effects of the three known phosphodiesterase type 5 inhibitors (PDE 5i)in patients with erectile dysfuction. Are there specific baseline characteristics that can influence the patients' tolerability and patients' reply to each PDE 5 inhibitor.

Interventions

The patients were treated with the three known phosphodiesterase type 5 (PDE 5) inhibitors (sildenafil 100mg, vardenafil 20mg and tadalafil 20mg) which were administered with incidental sequence. A week wash out period was followed after each of the three treatment period.All of them completed the International Index of Erectile Function 15 (IIEF-15) questionnaire following by a detailed medical and psychological history. Baseline variables examined were age, body mass index, alcohol consumption

The patients were treated with the three known phosphodiesterase type 5 (PDE 5) inhibitors (sildenafil 100mg, vardenafil 20mg and tadalafil 20mg) which were administered with incidental sequence. A week wash out period was followed after each of the three treatment period.All of them completed the International Index of Erectile Function 15 (IIEF-15) questionnaire following by a detailed medical and psychological history. Baseline variables examined were age, body mass index, alcohol consumption, smoking status, physical activity, Erectile dysfunction (ED) aetiology/duration, comorbidities in medical history, medication intake, psychological status and baseline scores for the IIEF domains. The maximum dose was used for at least 4 attempts for intercourse with each one of them (4 pills from each drug) during a 4-weeks period. The attempt for intercourse must be start at least 30 minutes after the oraly intake of the medication (single dose) and not earlier. If the patient wanted to try second intercourse within 24 hours, he would have tried with the same pill. He might take second one only after at least 24 hours. No other instructions were given (about food intake or drink consumption). In every follow up visit, the Sexual encounter Profile (SEP) diary were selected and the IIEF questionnaire was completed. The study for statistically reasons divided in four arms. The first arm included the first visit of the patient to the doctor (before medication). The second arm included the results after sildenafil 100mg intake. The third and the fourth after vardenafil 20mg and tadalafil 20mg respectively.

Sponsors

Toutziaris Chrysovalantis
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
Male
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

Erectile dysfunction for at least 6 months

Exclusion criteria

1) Myocardial infarction until 6 months ago 2) Nitrite drug administration 3) Present urogenital infection 4) PDE 5 inhibitor intake at least 3 months before the study begins 5) Peyronie disease or other anatomic disorders of the penis 6) The existence of a serious neurological problem such as multiple sclerosis or stroke or spinal cord injury 7) The existence of erectile dysfunction <6 months

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026