DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Erectile Dysfunction

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

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

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

Summary

Study to investigate the efficacy and safety of Vardenafil

Clinical Details

Official title: A Randomised, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy, Safety, and Reliability of 10mg Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction

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

Primary outcome: Sexual Encounter Profile question 2 (SEP 2)

Secondary outcome:

Sexual Encounter Profile question 3 (SEP 3)

International Index of Erectile Function (IIEF) - EF (Erectile Function) domain

Safety and Tolerability

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Heterosexual males

- >/= 18 years old with ED for more than six months

- Subjects also needed a positive first-time response to a single dose of 10mg

vardenafil to be eligible for randomisation Exclusion Criteria:

- Primary hypoactive sexual desire

- History of myocardial infarction, stroke or life-threatening arrhythmia within prior

6 month

- Nitrate therapy

- Other exclusion criteria apply according to the Summary of Product Characteristics

Locations and Contacts

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here to find results for studies related to Bayer Healthcare products.

Starting date: June 2003
Last updated: December 1, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017