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 31 sites in United States. Open to participants aged 21 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 compare the effects of sildenafil versus placebo on the female partner's sexual satisfaction as assessed by Question 3 of Female Partner of Erectile Dysfunction (ED) Subject Questionnaire (FePEDS-Q): "Over the past 4 weeks, when you had sexual intercourse, how often was it satisfactory for you?" For ED subjects, determine difference in the Erectile Function domain of International Index of Erectile Function (IIEF) between sildenafil citrate and placebo at end of the treatment phase and determine the overall relationship between improved erectile function and increased ED subject and female partner satisfaction.
683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.
This study's planned enrollment of 300 is above the median of 72 across 542 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.
Exclusion Criteria:
Drug: sildenafil
Drug: placebo
sildenafil 50 mg (initial dose) tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks; depending upon safety, efficacy and tolerability, the dose could be increased to 100 mg or reduced to 25 mg, if necessary.
placebo tablet by mouth 30 to 60 minutes prior to sexual activity for 12 weeks
Question 3 of the Female Partner ED Subject Questionnaire (FePEDS-Q) in female partners.
Time frame: Week 12
International Index of Erectile Function (IIEF) Erectile Function, Desire, Orgasm, Intercourse Satisfaction, and Overall Satisfaction Domains in ED patients
Time frame: Week 8 and Week 12
Self-Esteem and Relationship Questionnaire (SEAR) in ED patients
Time frame: Week 12
ED Subject Event Log in ED patients
Time frame: Week 12
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index of treatment satisfaction in ED patients
Time frame: Week 12
Dyadic Adjustment Scale (DAS) in ED patients
Time frame: Week 8 and Week 12
American Urological Association (AUA) Symptom Index in ED patients
Time frame: Week 12
Global Efficacy Assessment Questions (GEQ) in ED patients
Time frame: Week 12
Questions 1 and 2 of Female Partner of ED Subject Questionnaire (FePEDS-Q) in female partners
Time frame: Week 8 and Week 12
Sexual Function Questionnaire (SFQ) Desire, Arousal, Enjoyment and Orgasm Domains in female partners
Time frame: Week 12
Female Sexual Function Inventory (FSFI) Desire, Satisfaction and Arousal Domains in female partners
Time frame: Week 12
Partner EDITS in female partners
Time frame: Week 12
Female Partner Treatment Continuation Question in female partners
Time frame: Week 12
Dyadic Adjustment Scale (DAS) in female partners
Time frame: Week 8 and Week 12
Beck Depression Inventory (BDI-II) in female partners
Time frame: Week 12
Female Partner Event Log in female partners
Time frame: Week 12
AUA Symptom Index in female partners
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.