A Phase 4 interventional study of sildenafil and placebo in Erectile Dysfunction, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 67 sites in 8 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-01.
Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 4, Interventional, and Treatment
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.
682 studies on the registry are indexed under Erectile Dysfunction; 116 are open to participants now.
This study's enrollment of 780 is above the median of 72 across 541 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
-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:
Drug: placebo
Drug: sildenafil
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.
placebo tablet by mouth 1 hour before sexual activity for 12 weeks
Change from baseline in the Self-esteem domain of the SEAR questionnaire
Time frame: 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
Time frame: Week 12
Differences in the global efficacy assessment question overall and by type of co-morbidity
Time frame: Week 12
Differences in the global satisfaction assessment questions overall and by type of co-morbidity
Time frame: 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)
Time frame: Week 12
Changes in the sexual activity domain of the SEAR questionnaire overall and by type of co-morbidity
Time frame: Week 12
Changes in the relationship domain of the SEAR questionnaire overall and by type of co-morbidity
Time frame: Week 12
Changes of the SEAR questions overall and by type of co-morbidity
Time frame: Week 12
Changes of the IIEF questions overall and by type of co-morbidity
Time frame: Week 12
Changes of the IIEF domains overall and by type of co-morbidity
Time frame: Week 12
Degrees of severity in the IIEF erectile function
Time frame: 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
Time frame: Week 12
Changes in the questions from the event log overall and by type of co-morbidity
Time frame: 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
Time frame: Week 12
Differences in the intercourse success rates derived from the event log overall and by type of comorbidity
Time frame: Week 12
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.