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Sponsors and Collaborators: |
VIVUS, Inc. Quintiles |
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Information provided by: | VIVUS, Inc. |
ClinicalTrials.gov Identifier: | NCT00790751 |
This study is being conducted to compare the safety and efficacy of 3 doses of avanafil to placebo in men with mild to severe erectile dysfunction.
Condition | Intervention | Phase |
---|---|---|
Erectile Dysfunction |
Drug: placebo Drug: avanafil |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED EVALUATION OF THE SAFETY AND EFFICACY OF AVANAFIL (TA-1790) IN SUBJECTS WITH GENERALIZED ERECTILE DYSFUNCTION |
Estimated Enrollment: | 600 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator |
Drug: placebo
po 30 minutes before initiation of intercourse
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2: Experimental
avanafil 50 mg
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Drug: avanafil
po 30 minutes before initiation of intercourse
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3: Experimental
avanafil 100 mg
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Drug: avanafil
po 30 minutes before initiation of intercourse
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4: Experimental
avanafil 200 mg
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Drug: avanafil
po 30 minutes before initiation of intercourse
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Brenda Trask | 650-934-5235 | trask@vivus.com |
Study Director: | Chuck Bowden, MD | VIVUS, Inc. |
Responsible Party: | Vivus, Inc. ( Brenda Trask ) |
Study ID Numbers: | TA-301 |
Study First Received: | November 10, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00790751 |
Health Authority: | United States: Food and Drug Administration |
Erectile Dysfunction E.D. Dysfunction |
Sexual Dysfunctions, Psychological Sexual Dysfunction, Physiological Mental Disorders Genital Diseases, Male Erectile Dysfunction |
Sexual and Gender Disorders |