Clinical Proof-of-concept Study for the Combination BAY60-4552 / Vardenafil for the Treatment of Erectile Dysfunction Not Sufficiently Responsive to Standard Therapy With PDE5 Inhibitors

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT01168817

Collaborator

(none)

140

Enrollment

Locations

Arms

Duration (Months)

3.9

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study examines the efficacy and safety of the combination treatment BAY60-4552 plus vardenafil in patients with erectile dysfunction, who do not sufficiently respond to therapy with PDE5 (Phosphodiesterase 5) inhibitors.

Patients meeting the entry criteria, will receive vardenafil alone in the first four weeks of the study to assess the effect of PDE5 inhibitor therapy given alone.

Patients with an insufficient therapeutic response to vardenafil alone will enter the next part of the study, and will be randomly assigned to one of 3 treatments. There is a 1 in 3 chance of receiving either the combination BAY60-4552 plus vardenafil, or vardenafil alone, or placebo. Neither patient nor the treating physician will know which treatment is given (double-blinded design).This part of the study will last four weeks Patients will have to go to the clinic/hospital for 7 visits during the 8 weeks.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: BAY60-4552 plus Vardenafil Drug: Vardenafil Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Prospective, Randomized, Double-blind, Double-dummy, Placebo- and Active Controlled, Multicenter Study Assessing the Efficacy and Safety of the Combination BAY60-4552 / Vardenafil Compared to Vardenafil (20 mg) for the Treatment of Erectile Dysfunction Not Sufficiently Responsive to Standard Therapy With PDE5 (Phosphodiesterase 5) Inhibitors

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: BAY60-4552 plus Vardenafil Treatment with 3 tablets once daily for 4 weeks (Vardenafil 10 mg plus BAY60-4552 1.0 mg)
Active Comparator: Arm 2	Drug: Vardenafil Treatment with 3 tablets once daily for 4 weeks (Vardenafil 20 mg)
Placebo Comparator: Arm 3	Drug: Placebo Treatment with 3 tablets once daily for 4 weeks (Placebo)

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: BAY60-4552 plus Vardenafil

Treatment with 3 tablets once daily for 4 weeks (Vardenafil 10 mg plus BAY60-4552 1.0 mg)

Active Comparator: Arm 2

Drug: Vardenafil

Treatment with 3 tablets once daily for 4 weeks (Vardenafil 20 mg)

Placebo Comparator: Arm 3

Drug: Placebo

Treatment with 3 tablets once daily for 4 weeks (Placebo)

Outcome Measures

Primary Outcome Measures

Severity of erectile dysfunction assessed by the IIEF-EF (International Index of Erectile Function - Erectile Function subscale) [Week 4]

Secondary Outcome Measures

Success rate assessed by subject diary question: 'Maintenance' (Did your erection last long enough to have sexual intercourse?) [Week 4]
Success rate assessed by subject diary question: Penetration' (Were you able to insert your penis into your partner's vagina?) [Week 4]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Open-label run-in phase (first four weeks):
Written informed consent signed before any study-specific procedure
History of ED (Erectile Dysfunction) for at least 6 months prior to screening, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse"; the diagnosis of ED has to be confirmed by a physician
Stable, heterosexual relationship for at least 6 months prior to screening
Aged 18 to 64 years (inclusive) at the first screening examination
History of previous use of at least 1 marketed PDE5 (Phosphodiesterase 5) inhibitor and insufficient therapeutic efficacy despite use of the highest approved dose
Double-blind treatment phase (last four weeks):
At least 4 attempts at sexual intercourse on 4 separate days during the open-label run-in phase with use of 20 mg vardenafil approximately 1 hour before attempting intercourse
IIEF EF (International Index of Erectile Function - Erectile Function subscale) score <17
At least 50% of attempts at sexual intercourse during the open-label run-in phase were unsuccessful

Exclusion Criteria:

Contraindication to use of vardenafil
History of prostatectomy due to prostate cancer, including nerve-sparing techniques.
Concomitant use of adrenergic blockers
History of spinal cord injury
Resting hypotension, i.e. SBP (Systolic Blood Pressure) <100 mmHg at rest
Moderate / severe hypertension, i.e. SBP >170 mmHg or DBP >110 mmHg at rest
Symptomatic orthostatic hypotension with a decrease in SBP >20 mmHg or in DBP (Diastolic Blood Pressure) >10 mmHg subsequent to change from the supine to standing position

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Oulu		Finland	90100
2	Tampere		Finland	FIN-33520
3	Turku		Finland	20100
4	Chambery Cedex		France	73011
5	Garches		France	92380
6	Lille		France	59000
7	Lyon Cedex		France	69437
8	Nice		France	06200
9	Nimes		France	30000
10	Weiden	Bayern	Germany	92637
11	Marburg	Hessen	Germany	35039
12	Osnabrück	Niedersachsen	Germany	49076
13	Mülheim	Nordrhein-Westfalen	Germany	45468
14	Koblenz	Rheinland-Pfalz	Germany	56068
15	Leipzig	Sachsen	Germany	04105
16	Leipzig	Sachsen	Germany	04109
17	Hamburg		Germany	20246
18	Hamburg		Germany	20354
19	Firenze		Italy	50141
20	Milano		Italy	20132
21	Napoli		Italy	80131
22	Roma		Italy	00133
23	Den Haag		Netherlands	2545 CH
24	Groningen		Netherlands	9713 GZ
25	Leiden		Netherlands	2333 ZA
26	Aravaca	Madrid	Spain	28023
27	Majadahonda	Madrid	Spain	28222
28	Barcelona		Spain	08003
29	Barcelona		Spain	08036
30	Málaga		Spain	29007
31	Eskilstuna		Sweden	633 40
32	Göteborg		Sweden	405 45
33	Halmstad		Sweden	302 45
34	Jönköping		Sweden	554 66
35	Linköping		Sweden	581 85
36	Stockholm		Sweden	141 86