A Study Evaluating Vardenafil Compared to Placebo in Subjects With Erectile Dysfunction (ED) and Dyslipidemia - Full Text View

Purpose

This is a study consisting of four periods (screening, run-in, treatment, follow-up). A four-week treatment-free, run-in period where the subject will make at least four attempts at intercourse on four separate days with at least 50% of the attempts must be unsuccessful. During run-in the subjects will be using a stopwatch to measure the time from erection perceived hard enough for penetration until withdrawal from the partner's vagina. Next there are 12 weeks of treatment with either placebo or LEVITRA. Each subject will be required to visit the clinic on 5 occasions over a period of 4 months.

Condition	Intervention	Phase
Erectile Dysfunction (ED) Erectile Dysfunction	Drug: LEVITRA (vardenafil) Drug: placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy, Safety, and Duration of Erection of Flexible-dose Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction and Dyslipidemia

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil Vardenafil hydrochloride Vardenafil dihydrochloride Vardenafil hydrochloride trihydrate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

EF domain score of the International Index of Erectile Function (IIEF) at randomization and every 4 weeks during therapyDiary response: success of insertion and maintenance recorded at every attempt from randomization through end of treatment [ Time Frame: 12 week study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of erection and specific diary responses concerning satisfaction: every attemptResponse to diary questions and scores for Keep It Simple (KIS): randomization and every 4 weeksResponse to Global Assessment Question (GAQ): every 4 weeks [ Time Frame: 12 week study ] [ Designated as safety issue: No ]

Enrollment:	510
Study Start Date:	May 2006
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Levitra 10mg x 4 weeks, with option to increase to 20mg aat that time if desired	Drug: LEVITRA (vardenafil) active comparator Other Name: LEVITRA (vardenafil)
Placebo Comparator: placebo	Drug: placebo placebo comparator

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

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?
Diagnosis of dyslipidemia treated with a stable dose of a statin for 6 months at Visit 1.
IIEF-EF domain score of 25 denoting mild to severe ED at Visit 2.
Documented, dated, written Informed Consent.

Exclusion criteria:

Premature ejaculator <2 minutes
Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities, or substance abuse disorder that MD feels subject will not be able to complete the study.
Low sexual desire.
Prior prostatectomy surgery
Severe chronic or acute liver disease, history of moderate or severe liver impairment
Clinically significant chronic hematological disease
Bleeding disorder or significant active peptic ulceration.
Cardiovascular conditions that prevent sexual activity.
History of heart attack, stroke, or life-threatening arrhythmia within the prior 6 months.
hypotension or hypertension at rest.
cancer within the past 5 years. Use of these medications: nitrates or nitric oxide donors, anti-androgens, oral or injectable androgens, received any investigational drug (including placebo) within 30 days of screening (Visit 1).
Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories.
Subjects who are taking the following potent inhibitors of cytochrome P-450 3A4.
Abnormal Laboratory Values:
1. serum total testosterone level >25% below the lower limit of normal
2. serum creatinine >3.0 mg/dl.
3. AST and/or ALT >3x the upper limit of normal.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379756

Show 57 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00379756 History of Changes
Other Study ID Numbers:	106718
Study First Received:	September 21, 2006
Last Updated:	June 7, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Erectile dysfunction, impotence

Additional relevant MeSH terms:

Dyslipidemias
Erectile Dysfunction
Lipid Metabolism Disorders
Metabolic Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

Vardenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013