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BAY38-9456 - Pivotal Trial for Diabetes Patient

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

Condition(s) targeted: Erectile Dysfunction; Diabetes Mellitus

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

The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg regimens. Overall the tolerability was considered good with both regimens.

Clinical Details

Official title: A Randomized, Placebo-controlled, Double-blind, Multi-centre, Parallel Group Study to Investigate the Efficacy and Safety of BAY 38-9456 in Males With Diabetes Suffering From 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: The Erectile Function (EF) domain score of IIEF calculated as the sum of scores from Questions 1 to 5 and 15

Secondary outcome:

The Global Assessment Question

The IIEF EF domain score

IIEF domain scores other than the EF domain score[intercourse satisfaction (Q6 to Q8), overall satisfaction (Q13, Q14), orgasmic function (Q9, Q10), sexual desire (Q11, Q12)]

Scores of Questions 1 to 15 on the IIEF Questionnaire

Patient's diary response concerning hardness of erection, maintenance of erection, satisfaction with overall hardness of erection, ability of insertion, overall satisfaction with sexual experience and ejaculation

Safety data

Eligibility

Minimum age: 20 Years. Maximum age: 64 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Male with erectile dysfunction for more than 3 years according to the National

Institutes of Health (NIH) Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)

- Diabetes for more than 3 years

Exclusion Criteria:

- Following to the labeling of Japanese package insert for vardenafil 5/10 mg, except

for the highest dose

- Spinal cord injury

- History of surgical prostatectomy (excluding TURP)

- Patients with an HbA1c > 12% at Visit 1

- Use of nitrates

- Use of potent CYP3a4 inhibitors

- Severe liver disease

- Presence of Peyronie's Disease

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: January 2004
Last updated: December 18, 2014

Page last updated: August 23, 2015

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