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

Sexual Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00377793
• Other study ID #: 12146
• Secondary ID: EudraCT 2006-001
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2006
• Last updated: December 23, 2014
• Start date: July 2006
• Est. completion date: August 2007

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of MedicinesGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Male Erectile Dysfunction
• Sexual Dysfunction

Intervention

Drug:
• Levitra (Vardenafil, BAY38-9456)

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Netherlands,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maintenance of erection in men with ED, Improvement of their female partners sexual quality of life		12 weeks	No
Secondary	SEP3 at weeks 4, 12, 18, and 24 of treatment compared to placebo		24 weeks	No
Secondary	Additional Subject Diary questions at weeks 4, 12, 18, and 24, LOCF, and over entire treatment period compared to placebo		24 weeks	No
Secondary	Global confidence question (GCQ) at weeks 12, and 24 of treatment compared to placebo. IIEF, TSS, mSLQQ-QOL, Partnership questionnaire (PFB20)		24 weeks	No

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