Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00786253

Collaborator

(none)

236

Enrollment

Locations

Arms

Duration (Months)

12.4

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Compare once daily vs on demand treatment in men with erectile dysfunction.

Treatment of mild to moderate erectile dysfunction with 10 mg vardenafil p.o. over 24 weeks + 4 weeks wash-out:

A: once daily at bedtime for 12 weeks followed by 12 weeks of placebo B: once daily at bedtime for 24 weeksC: PRN for 24 weeks

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456) Drug: Levitra (Vardenafil, BAY38-9456)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

236 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Explorative, Double-blind, Double-dummy, Multi-center, Parallel Group Study to Assess Sustainable Efficacy of Once Daily Vardenafil (10 mg) for 12 and 24 Weeks Versus Vardenafil PRN in Men With Mild or Mild to Moderate ED

Study Start Date :

Oct 1, 2005

Actual Study Completion Date :

Jan 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456) Vardenafil 10 mg on demand use
Experimental: Arm 2	Drug: Levitra (Vardenafil, BAY38-9456) Vardenafil daily dosing 10 mg

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Levitra (Vardenafil, BAY38-9456)

Vardenafil 10 mg on demand use

Experimental: Arm 2

Drug: Levitra (Vardenafil, BAY38-9456)

Vardenafil daily dosing 10 mg

Outcome Measures

Primary Outcome Measures

Erectile Dysfunction change score from baseline of the ED change score from baseline of the International Index of Erectile Function (IIEF-EF) [12- 24 weeks]

Secondary Outcome Measures

SEP 2 [12- 24 weeks]
SEP 3 [12- 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Males 18-64 years of age
Mild or mild to moderate ED (defined as >15 and <21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit)
History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease
Stable, heterosexual relationship for more than six months

Exclusion Criteria:

Primary hypoactive sexual desire
History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
Nitrate therapy.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Tübingen	Baden-Württemberg / 277	Germany	72076
2	München	Bayern / 280	Germany	81925
3	Regensburg	Bayern / 280	Germany	93053
4	Weiden	Bayern / 280	Germany	92637
5	Berlin	Berlin / 285	Germany	12200
6	Hamburg	Hamburg / 287	Germany	20251
7	Hamburg	Hamburg / 287	Germany	20354
8	Hamburg	Hamburg / 287	Germany	22299
9	Marburg	Hessen / 307	Germany	35039
10	Hagenow	Mecklenburg-Vorpommern / 309	Germany	19230
11	Hannover	Niedersachsen / 291	Germany	30625
12	Osnabrück	Niedersachsen / 293	Germany	49076
13	Düsseldorf	Nordrhein-Westfalen / 296	Germany	40225
14	Münster	Nordrhein-Westfalen / 298	Germany	48149
15	Leverkusen	Nordrhein-Westfalen / 331	Germany	51375
16	Grevenbroich	Nordrhein-Westfalen / 623	Germany	41515
17	Leipzig	Sachsen / 313	Germany	04249
18	Meißen	Sachsen / 313	Germany	01662
19	Halle	Sachsen-Anhalt / 311	Germany	06097