Erectile Dysfunction
Conditions
Brief summary
To determine the improvement in the self-esteem domain score of the Self-Esteem/Overall Relationship (SEAR) questionnaire and the improvement in erectile function (obtained from the Erectile Function \[EF\] domain of the International Index of Erectile Function \[IIEF\]). Furthermore, to determine if the improvement obtained in self-esteem was related to the main erectile dysfunction (ED) co-morbidities type and/or number.
Interventions
DRUGsildenafil
sildenafil 50 mg tablet by mouth 1 hour before sexual activity for 12 weeks; the dose could be increased to 100 mg or decreased to 25 mg.
DRUGplacebo
placebo tablet by mouth 1 hour before sexual activity for 12 weeks
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Men with a documented clinical diagnosis of ED confirmed by a Sexual Health Inventory-Male (SHI-M) score of 21 or less and who have a sexual partner for the duration of the study were included.
Exclusion criteria
* Subjects who have previously taken, or it is suspected they have taken, more than 4 doses of sildenafil citrate, or any other phosphodiesterase type 5 (PDE-5) inhibitor, or apomorphine, at any time prior to the screening visit or patients who have taken any dose of these compounds in the last two months * Subjects with resting sitting hypotension (BP \< 90/50mmHg) or hypertension (BP \> 170/110mmHg) * Subjects with significant cardiovascular disease, including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischaemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias in the last 3 months * Patients on nitrates.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the Self-esteem domain of the SEAR questionnaire | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Differences in the global efficacy assessment question overall and by type of co-morbidity | Week 12 |
| Differences in the global satisfaction assessment questions overall and by type of co-morbidity | Week 12 |
| Comparisons between treatments in the SE domain of the SEAR questionnaire by type of co-morbidity (hypertension, hyperlipidemia, diabetes mellitus, benign prostatic hyperplasia, depression) | Week 12 |
| Changes in the sexual activity domain of the SEAR questionnaire overall and by type of co-morbidity | Week 12 |
| Changes in the relationship domain of the SEAR questionnaire overall and by type of co-morbidity | Week 12 |
| Changes of the SEAR questions overall and by type of co-morbidity | Week 12 |
| Correlation between the change in the SE domain of the SEAR questionnaire and the erectile function domain of the IIEF by number of ED co-morbidities | Week 12 |
| Changes of the IIEF domains overall and by type of co-morbidity | Week 12 |
| Degrees of severity in the IIEF erectile function | Week 12 |
| Correlation between the change in the SE domain of the SEAR questionnaire and the erectile function domain of the IIEF overall and by type of co-morbidity | Week 12 |
| Changes in the questions from the event log overall and by type of co-morbidity | Week 12 |
| Correlation between each success rate derived from the event log and the change in the SE domain of the SEAR questionnaire overall and by type of co-morbidity | Week 12 |
| Differences in the intercourse success rates derived from the event log overall and by type of comorbidity | Week 12 |
| Changes of the IIEF questions overall and by type of co-morbidity | Week 12 |
Countries
Finland, France, Italy, Poland, Russia, Spain, Sweden, United Kingdom
Outcome results
None listed