Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II
NCT ID: NCT00377793
Last Updated: 2014-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
352 participants
INTERVENTIONAL
2006-07-31
2007-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1
Levitra (Vardenafil, BAY38-9456)
Arm 2
Placebo
Interventions
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Levitra (Vardenafil, BAY38-9456)
Placebo
Eligibility Criteria
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Inclusion Criteria
* Males with ED for more than six months, according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
* Stable heterosexual relationship for more than 6 months
* The subject must make at least four attempts at sexual intercourse
* Females 18 years, and older
* Stable, heterosexual relationship for more than 6 months with male ED subject
* Documented, dated, written Informed Consent
* Motivated to support treatment for male partner's ED
* Absence of significant sexual dysfunction as assessed by the total score on the FSFI16 \> 23.55
Exclusion Criteria
* Subjects who are taking nitrates or nitric oxide donors
* Subjects who are taking the following inhibitors of cytochrome P 450 CYP 3A4: very potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents traconazole and ketoconazole (topical forms are allowed) or erythromycin
* Known hypersensitivity to vardenafil
* Presence of significant penile anatomical abnormalities (e.g. penile fibrosis or Peyronie's disease)
* History of retinitis pigmentosa
* Unstable angina pectoris
* Severe chronic or acute liver disease
* Premature ejaculator (defined as IELT \< 2 minutes)
* Subjects who were taking alpha blockers
* Presence of sexual dysfunction as assessed by the FSFI16 \< 23.55
* Any unstable medical condition or substance abuse disorder that, in the opinion of the Investigator, is likely to affect the partner's ability to complete the study or precludes the partner's participation in the study
18 Years
64 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer Schering Pharma AG
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Bruxelles - Brussel, , Belgium
Genk, , Belgium
Leuven, , Belgium
Liège, , Belgium
Roeselare, , Belgium
La Rochelle, , France
Lille, , France
Lyon, , France
Marseille, , France
Marseille, , France
Mont-de-Marsan, , France
Paris, , France
Toulouse, , France
Hamburg, Hamburg / 287, Germany
Hamburg, Hamburg / 287, Germany
Hamburg, Hamburg / 287, Germany
Hanover, Niedersachsen / 291, Germany
Brühl, Nordrhein-Westfalen / 325, Germany
Mülheim, Nordrhein-Westfalen / 481, Germany
Wuppertal, Nordrhein-Westfalen / 616, Germany
Bautzen, Sachsen / 313, Germany
Dresden, Sachsen / 313, Germany
Leipzig, Sachsen / 313, Germany
Leisnig, Sachsen / 313, Germany
Meißen, Sachsen / 313, Germany
Wahlstedt, Schleswig-Holstein / 306, Germany
Bergamo, , Italy
Florence, , Italy
Milan, , Italy
Napoli, , Italy
Roma, , Italy
Arnhem, , Netherlands
Deventer, , Netherlands
Enschede, , Netherlands
Nijverdal, , Netherlands
Bloemfontein, Free State, South Africa
Johannesburg, Gauteng, South Africa
Durban, KwaZulu-Natal, South Africa
Durban, KwaZulu-Natal, South Africa
Newcastle, KwaZulu-Natal, South Africa
Alicante, Alicante, Spain
Barcelona, Barcelona, Spain
La Roca del Vallès, Barcelona, Spain
Barcelona, Catalonia, Spain
Vigo, Pontevedra, Spain
San Cristóbal de La Laguna, Tenerife, Spain
Valencia, Valencia, Spain
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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EudraCT 2006-001228-37
Identifier Type: -
Identifier Source: secondary_id
12146
Identifier Type: -
Identifier Source: org_study_id