Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II

Study Overview
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Brief Summary
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This trial is to provide additional important information on the impact of the treatment of the man its ED with vardenafil on partnership. This study is being run at up to 50 study centers in Europe and South Africa to evaluate the use of vardenafil in adult men with erectile dysfunction (often called impotence), and their female partner's sexual quality of life. Many men experience occasional erectile problems during their lives. However, when this becomes a continued problem, it can affect both the man and his female partner. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to 1) study the effectiveness and safety of vardenafil, and 2) show whether treating a man its erectile dysfunction with vardenafil will improve his female partner its sexual quality of life. The second part (week 12) of the study (Educational program) a subgroup of subjects/couples, approximately 50% of the randomized subjects, will receive an educational program concerning ED in the from of a DVD.

Official Title
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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

Conditions
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Sexual Dysfunction, Male Erectile Dysfunction

Intervention / Treatment
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* Drug: Levitra (Vardenafil, BAY38-9456)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br> <br> |
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of erection in men with ED, Improvement of their female partners sexual quality of life |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placebo |  | 24 weeks | 
| Additional Subject Diary questions at weeks 4, 12, 18, and 24, LOCF, and over entire treatment period compared to placebo |  | 24 weeks | 
| Global confidence question (GCQ) at weeks 12, and 24 of treatment compared to placebo. IIEF, TSS, mSLQQ-QOL, Partnership questionnaire (PFB20) |  | 24 weeks |