A Phase 4 interventional study of Levitra (Vardenafil, BAY38-9456) and Placebo in Erectile Dysfunction, sponsored by Bayer. Completed. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-10-11.
Sponsored by Bayer · Phase 4, Interventional, and Treatment
This study is being conducted in US to obtain information on the efficacy, safety, and duration of erection of flexible-dose regime of vardenafil compared to placebo (dummy medication with no pharmacological activity), in patients with co-morbid factors associated with erectile dysfunction (also called impotence). The duration of erection endpoint will be assessed by patient utilized stopwatch timings during each attempt at sexual intercourse. Elevated levels of total cholesterol or low levels of HDL may result in atherosclerosis and induce erectile dysfunction. Vardenafil (Levitra) is approved by the Food and Drug Administration for the treatment of erectile dysfunction. While there is no intent to assess the effect vardenafil has on blood lipids, the study will provide prospective data on men diagnosed with both ED and dyslipidemia.
698 studies on the registry are indexed under Erectile Dysfunction; 116 are open to participants now.
This study's enrollment of 395 is above the median of 72 across 552 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: Levitra (Vardenafil, BAY38-9456)
Drug: Placebo
10mg Vardenafil taken orally 1h prior to sexual intercourse
Matching placebo
Sexual Encounter Profile Question 2 and 3 and International Index of Erectile Function - Erectile Function domain
Time frame: 12 weeks
Duration of erection leading to positive Sexual Encounter Profile Question 3
Time frame: 12 weeks
Safety and tolerability
Time frame: 12 weeks
Other patient diary based variables
Time frame: 12 weeks
No study locations are listed for this record.
The record gives a start of May 2006 and a completion of Apr 2007. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Vardenafil