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

Bayer

Status and phase

Completed

Phase 4

Conditions

Male Erectile Dysfunction

Sexual Dysfunction

Treatments

Drug: Placebo

Drug: Levitra (Vardenafil, BAY38-9456)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00377793

EudraCT 2006-001228-37

12146

Details and patient eligibility

About

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.

Enrollment

352 patients

Sex

Male

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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