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

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379756
• Other study ID #: 106718
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2006
• Last updated: August 14, 2017
• Start date: May 22, 2006
• Est. completion date: May 17, 2007

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 395
• Est. completion date: May 17, 2007
• Est. primary completion date: May 17, 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias
• Erectile Dysfunction

Intervention

Drug:
• LEVITRA (vardenafil)
active comparator
• placebo
placebo comparator

Locations

Country	Name	City	State
United States	GSK Investigational Site	Amarillo	Texas
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Aventura	Florida
United States	GSK Investigational Site	Avon	Indiana
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Columbus	Georgia
United States	GSK Investigational Site	Concord	California
United States	GSK Investigational Site	Coral Gables	Florida
United States	GSK Investigational Site	Dawsonville	Georgia
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Fairhope	Alabama
United States	GSK Investigational Site	Fayetteville	North Carolina
United States	GSK Investigational Site	Fort Myers	Florida
United States	GSK Investigational Site	Fort Wayne	Indiana
United States	GSK Investigational Site	Homewood	Alabama
United States	GSK Investigational Site	Huntington Park	California
United States	GSK Investigational Site	Huntsville	Alabama
United States	GSK Investigational Site	Jeffersonville	Indiana
United States	GSK Investigational Site	Kalamazoo	Michigan
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Lawrenceville	New Jersey
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Madisonville	Kentucky
United States	GSK Investigational Site	Menomonee Falls	Wisconsin
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Modesto	California
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New Britain	Connecticut
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Newport Beach	California
United States	GSK Investigational Site	Norfolk	Virginia
United States	GSK Investigational Site	North Miami	Florida
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Orangevale	California
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Pembroke Pines	Florida
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pinecrest	Florida
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Roswell	Georgia
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	Saint Louis Park	Minnesota
United States	GSK Investigational Site	Saint Petersburg	Florida
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	Santa Ana	California
United States	GSK Investigational Site	Sarasota	Florida
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Shippensburg	Pennsylvania
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	South Miami	Florida
United States	GSK Investigational Site	Swansea	Maine
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Taunton	Massachusetts
United States	GSK Investigational Site	Walnut Creek	California
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	West Seneca	New York
United States	GSK Investigational Site	Wheat Ridge	Colorado
United States	GSK Investigational Site	Wichita	Kansas
United States	GSK Investigational Site	Winston-Salem	North Carolina
United States	GSK Investigational Site	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)	The IIEF questionnaire is a validated 15-item instrument that assesses the participant's erectile function over the previous 4 weeks. The IIEF includes 5 domains affecting male sexual function: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Responses to the IIEF were re-coded using a standard coding method, where more positive responses received a higher score. The EF domain score was calculated as the sum of the re-coded scores from questions 1-5 and 15, using last observation carried forward (LOCF). Scores range from 1 (lowest) to 30 (highest). If two or more items in the EF domain were missing, the EF domain score was considered to be missing.	Up to Week 12
Primary	Mean success rate of insertion based on attempts	Success rate of insertion was derived from the Sexual Encounter Profile (SEP) Question 2 (SEP-2) of the participant's diary that asked 'Were you able to insert your penis into your partner's vagina?'. Responses were either Yes or No. Patients were instructed to complete diary questions as soon as possible after each sexual attempt, but no later than 24 hours after the attempt. The per-participant overall success rate for insertion was calculated by dividing the number of successful attempts (SEP-2=yes) over 12 weeks by the total number of valid attempts recorded over 12 weeks. If the participant was not able to make any valid attempts in 12 weeks, the participant was non-evaluable. Per-participant success rates were then averaged at the group level to obtain the mean success rate from Weeks 0-12.	Up to Week 12
Primary	Mean success rates of maintenance based on attempts	Success rate of maintenance was derived from the SEP Question 3 (SEP-3) of the participant's diary that asked 'Did your erection last long enough for you to have successful intercourse?'. Responses were either Yes or No. Participants were instructed to complete diary questions as soon as possible after each sexual attempt, but no later than 24 hours after the attempt. The per-participant overall success rate for maintenance was calculated by dividing the number of successful attempts (SEP-3=yes) over 12 weeks by the total number of valid attempts recorded over 12 weeks. If the participant was not able to make any valid attempts in 12 weeks, the participant was non-evaluable. Per-participant success rates were then averaged at the group level to obtain the mean success rate from Weeks 0-12.	Up to Week 12
Secondary	Mean duration of erection leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 [SEP-3]	Duration of erection leading to completion of successful intercourse was derived from data recorded in the participant's diary. For each diary entry, the time from erection perceived hard enough for penetration until withdrawal from partner's vagina was measured by stopwatch and recorded in the participant's diary. For diary entries where SEP-3=yes, this recorded duration was used in calculations of a per-participant median duration. For diary entries where SEP-3=no, a duration of 0 was used to calculate the per-participant median. The per-participant median values averaged at the group level to obtain the mean duration of erection leading to completion of successful intercourse as measured by SEP-3.	Up to Week 12
Secondary	Change from Baseline in scores for questions on the IIEF questionnaire and scores of the other non-EF domains of the IIEF	Non-EF domains of the IIEF (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, Overall Satisfaction) and IIEF questions (Erection during sexual activity?, Hard enough for penetration?, Able to penetrate partner?, Maintain your erection?, Maintain to completion?, Times attempted intercourse, Satisfactory for you?, Enjoyed sexual intercourse?, How often did you ejaculate?, How often feeling of orgasm?, How often felt sexual desire?, Rate level of sexual desire?, How satisfied with sex life?, Satisfied with sexual relationship? and Confidence to get, keep erection?) scores were assessed at Week 4, Week 8 and Week 12. The Baseline was the value at Week 0. Change from Baseline was the post-Baseline value minus Baseline value.	Up to Week 12
Secondary	Number of participants with normal erectile function having EF domain scores of 26 and above	The EF domain score was calculated by summing recoded responses to Questions 1-5 and 15, for each participant. It ranged from 1 to 30. EF domain scores were dichotomized as either normal (26 and above) or below normal (below 26) using LOCF, to calculate number of participants returning to normal erectile function. For the EF domain score the total was considered to be missing if 2 or more answers in the domain were missing.	Up to Week 12
Secondary	Change from Baseline in participant's diary results	Electronic diaries were provided to participants. Participants were supposed to complete the diary questions as soon as possible after each sexual attempt but no later than 24 hours after the attempts. The diary questions (Ability to achieve at least some erection, Ability to insert penis into partner's vagina, Long enough erection having successful intercourse, Satisfied with the hardness of erection, Satisfied with this sexual experience, Ability to ejaculate) response rates were presented for Weeks 0-12. The Baseline was the value at Week 0. Change from Baseline was the post-Baseline value minus Baseline value.	Up to Week 12
Secondary	Mean duration of erection regardless of SEP-3 Response	Duration of erection was time from erection perceived hard enough for penetration (start stopwatch) until withdrawal from the partner's vagina (stop stopwatch) regardless of completion of successful intercourse. The data was presented for overall period from Week 0 to Week 12.	Up to Week 12
Secondary	Change from Baseline in duration of erection leading to completion of successful intercourse.	Duration of erection was time from erection perceived hard enough for penetration (start stopwatch) until withdrawal from the partner's vagina (stop stopwatch) leading to completion of successful intercourse. The data was presented for overall period from Week 0 to Week 12. The Baseline was the value at Week 0. Change from Baseline was the post-Baseline value minus Baseline value.	Up to Week 12
Secondary	Number of participants with response 'Yes' for Global Assessment Question	The participants were asked to complete the self-administered Global Assessment Question. The question asked was 'has the treatment you have been taking over the past 4 weeks improved your erections'. The response was either Yes or No depending on comparison to participant's erections before their participation in this study. For the scale missing values remained missing.	Up to Week 12
Secondary	Mean score for Keep It Simple (KIS) scale	The KIS scale was a self-reported visual analog scale (VAS) from 0 to 10 designed to assess erections as 'how do you grade your erections over the last 4 weeks?'. For the scale missing values remained as missing.	Up to Week 12