Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II
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ClinicalTrials.gov Identifier: NCT00377793 |
Recruitment Status :
Completed
First Posted : September 18, 2006
Last Update Posted : December 24, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sexual Dysfunction Male Erectile Dysfunction | Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 352 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double Blind, Parallel Group Study of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction and Their Female Partners Sexual Quality of Life. PARTNER II |
Study Start Date : | July 2006 |
Actual Study Completion Date : | August 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1 |
Drug: Levitra (Vardenafil, BAY38-9456) |
Placebo Comparator: Arm 2 |
Drug: Placebo |
- Maintenance of erection in men with ED, Improvement of their female partners sexual quality of life [ Time Frame: 12 weeks ]
- SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placebo [ Time Frame: 24 weeks ]
- Additional Subject Diary questions at weeks 4, 12, 18, and 24, LOCF, and over entire treatment period compared to placebo [ Time Frame: 24 weeks ]
- Global confidence question (GCQ) at weeks 12, and 24 of treatment compared to placebo. IIEF, TSS, mSLQQ-QOL, Partnership questionnaire (PFB20) [ Time Frame: 24 weeks ]

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males 18 to 64 years
- 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
- Documented, dated, written Informed Consent Inclusion Criteria Partner
- 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:
- Any unstable medical condition or substance abuse disorder that, in the opinion of the Investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study
- 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
- Lost of vision of one eye because of NAION Exclusion Criteria Partner
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377793
Belgium | |
Bruxelles - Brussel, Belgium, 1000 | |
Genk, Belgium, 3600 | |
Leuven, Belgium, 3000 | |
Liege, Belgium, 4000 | |
Roeselare, Belgium, 8800 | |
France | |
La Rochelle, France, 17000 | |
Lille, France, 59000 | |
Lyon, France, 69000 | |
Marseille, France, 13009 | |
Marseille, France, 13275 | |
Mont-de-marsan, France, 40000 | |
Paris, France, 75009 | |
Toulouse, France, 31000 | |
Germany | |
Hamburg, Hamburg / 287, Germany, 20251 | |
Hamburg, Hamburg / 287, Germany, 20354 | |
Hamburg, Hamburg / 287, Germany, 22177 | |
Hannover, Niedersachsen / 291, Germany, 30625 | |
Brühl, Nordrhein-Westfalen / 325, Germany, 50321 | |
Mülheim, Nordrhein-Westfalen / 481, Germany, 45468 | |
Wuppertal, Nordrhein-Westfalen / 616, Germany, 42103 | |
Bautzen, Sachsen / 313, Germany, 02625 | |
Dresden, Sachsen / 313, Germany, 01129 | |
Leipzig, Sachsen / 313, Germany, 04105 | |
Leisnig, Sachsen / 313, Germany, 04703 | |
Meißen, Sachsen / 313, Germany, 01662 | |
Wahlstedt, Schleswig-Holstein / 306, Germany, 23812 | |
Italy | |
Bergamo, Italy, 24128 | |
Firenze, Italy, 50139 | |
Milano, Italy, 20132 | |
Napoli, Italy, 80131 | |
Roma, Italy, 00155 | |
Netherlands | |
Arnhem, Netherlands, 6836 BH | |
Deventer, Netherlands, 7415 EH | |
Enschede, Netherlands, 7511 JX | |
Nijverdal, Netherlands, 7442 LS | |
South Africa | |
Bloemfontein, Free State, South Africa, 9324 | |
Johannesburg, Gauteng, South Africa, 2090 | |
Newcastle, Kwa Zulu-Natal, South Africa, 2940 | |
Durban, KwaZulu Natal, South Africa, 4037 | |
Durban, KwaZulu Natal, South Africa, 4091 | |
Spain | |
La Roca del Vallès, Barcelona, Spain, 08430 | |
Barcelona, Cataluña, Spain, 08025 | |
Vigo, Pontevedra, Spain, 36211 | |
La Laguna, Tenerife, Spain, 38320 | |
Alicante, Spain, 03010 | |
Barcelona, Spain, 08034 | |
Valencia, Spain, 46010 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Medical Affairs Therapeutic Area Head, Bayer Schering Pharma AG |
ClinicalTrials.gov Identifier: | NCT00377793 |
Other Study ID Numbers: |
12146 EudraCT 2006-001228-37 |
First Posted: | September 18, 2006 Key Record Dates |
Last Update Posted: | December 24, 2014 |
Last Verified: | December 2014 |
Erectile Dysfunction Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Mental Disorders Vardenafil Dihydrochloride Vasodilator Agents |
Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Urological Agents |