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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00661115
Other study ID # 10695
Secondary ID
Status Completed
Phase Phase 3
First received April 15, 2008
Last updated December 15, 2014
Start date May 2003
Est. completion date February 2004

Study information

Verified date December 2014
Source Bayer
Contact n/a
Is FDA regulated No
Health authority India: Drugs Controller General of India
Study type Interventional

Clinical Trial Summary

To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.


Recruitment information / eligibility

Status Completed
Enrollment 173
Est. completion date February 2004
Est. primary completion date February 2004
Accepts healthy volunteers No
Gender Male
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Men 21 years or above with ED for more than 6 months with normal libido and stable heterosexual relationship of at least 6 months

- having at least a 50% failure rate of sexual intercourse attempts during the run-in phase

Exclusion Criteria:

- Subjects with penile abnormalities, hypogonadism, history of unstable angina pectoris for 6 months or less, myocardial infarction, life threatening arrhythmia and history of unresponsiveness to sildenafil were excluded.

- Diabetic subjects with hemoglobin A1c (HbA1c) more than 12% were also excluded.

- Subjects could not be on androgens/anti-androgens or alpha blockers.

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Levitra (Vardenafil, BAY38-9456)
Vardenafil 10 mg. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks
Placebo
Placebo. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)calculated as the sum of scores from Questions 1 to 5 and 15 At Week 12 using the Last Observation Carried Forward (LOCF) method to account for dropouts. No
Secondary Success in penetration and maintenance as recorded in subject diaries At Weeks 4, 8 and 12 (as observed and at LOCF) No
Secondary Scores for questions 3 and 4 of the IIEF At Weeks 4, 8 and 12 (as observed and at LOCF) No
Secondary Other IIEF domain scores At Week 12 (observed and at LOCF) No
Secondary Global Assessment Question (GAQ) responses At Weeks 4, 8 and 12 (as observed and at LOCF) No
Secondary Rates of premature termination, adverse events, laboratory abnormalities, ECG abnormalities, and concomitant medication use. At Weeks 4, 8 and 12 (as observed and at LOCF) Yes
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