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

Condition(s) targeted: Sexual Dysfunction; Male Erectile Dysfunction

Intervention: Levitra (Vardenafil, BAY38-9456) (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Manager, Study Director, Affiliation: Bayer

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: 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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Success of maintenance of erection in men with ED. Improvement of their female partners sexual quality of life.

Secondary outcome:

SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placebo, Additional Subject Diary questions at weeks 4, 12, 18, and 24, LOCF, and over entire treatment period compared to placebo

Global confidence question (GCQ) at weeks 12, and 24 of treatment compared to placebo. IIEF, TSS, mSLQQ-QOL, Partnership questionnaire (PFB20)

Detailed description: Number of arms: 2

A four week double-blind treatment period with randomized subject allocation to either 10 mg per dose of vardenafil or placebo.

A subsequent 8 week double-blind treatment period during which subjects stay on the assigned treatment of vardenafil or placebo. They will either maintain the previous dosage regimen or will step up to 20 mg per dose of vardenafil / placebo or will step down to 5 mg per dose of vardenafil / placebo.

Exploratory phase of the study starting at Week 12 of double blind treatment: Educational program.

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Male.

Criteria:

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 (according to the

question in the subject diary: "Was sexual activity initiated with the intention of intercourse?" on four separate days during the untreated baseline period. At least 50% of attempts during this period must be unsuccessful, according to the following questions from the subject diary [at least one question should be answered "No"]: "Were you able to achieve at least some erection (some enlargement of the penis)?" "Were you able to insert your penis into your partner's vagina?" "Did your erection last long enough for you to have successful 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

Bayer Clinical Research Center, ask Contact, Belgium

Bayer Clinical Research Center, ask Contact, France

Bayer Clinical Research Center, ask Contact, Germany

Bayer Clinical Research Center, ask Contact, Netherlands

Bayer Clinical Research Center, ask Contact, South Africa

Bayer Clinical Research Center, ask Contact, Spain

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Starting date: July 2006
Last updated: June 26, 2007