Study Evaluating the Effects of Avanafil on Semen Parameters



Status:Completed
Conditions:Erectile Dysfunction
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 45
Updated:4/21/2016
Start Date:December 2012
End Date:August 2014

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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Clinical Trial of the Effect of Avanafil (STENDRA™) on Spermatogenesis in Healthy Adult Males and Adult Males With Mild Erectile Dysfunction

The purpose of this study is to determine whether avanafil will affect different aspects of
sperm production.


Inclusion Criteria:

- Provide written informed consent

- Able to produce semen samples without requiring therapy (PDE5 inhibitors,
over-the-counter (OTC) medication, and/or herbal supplements) for erectile
dysfunction

- Be medically healthy (no clinically significant screening results for medical
history, electrocardiogram (ECG), laboratory studies, physical examination, etc.) in
the opinion of the investigator

- Be willing and able to comply with all study requirements

Exclusion Criteria:

- An International Index of Erectile Function (IIEF) erectile function domain score of
less than 17;

- History of infertility, vasectomy, testicular mass, testicular trauma, testicular
abnormality (including size), radiation to the testis, previous pelvic surgery,
cryotherapy of the prostate, known sperm defect, or retrograde ejaculation, or
cryptorchidism;

- Resting heart rate <45 or >90 beats per minute at screening (3 rechecks permitted);

- Screening systolic blood pressure <90 or >140 mmHg and/or diastolic blood pressure
<50 or >90 mmHg (3 rechecks permitted);

- High serum FSH (>18.0 mIU/mL), high serum LH (>18 mIU/mL), or low serum testosterone
(< 270 ng/dL, early morning collection) on screening;

- AST or ALT >2.0 x ULN or other evidence of significant hepatic impairment;

- Prostate specific antigen (PSA) level ≥4 ng/mL at screening;

- Individuals who perform rotating shift work during the course of the study.
We found this trial at
15
sites
Parker, Colorado
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Albany, New York
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Albany, NY
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Aventura, Florida
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Aventura, FL
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Bala Cynwyd, Pennsylvania
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Bala Cynwyd, PA
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Carmel, Indiana
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Carmel, IN
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Cincinnati, Ohio 45229
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Cincinnati, OH
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Huntsville, Alabama
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Huntsville, AL
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Kansas City, Missouri
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Kansas City, MO
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Knoxville, Tennessee
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Knoxville, TN
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LA, California 90089
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LA, CA
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New Orleans, Louisiana 70115
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New Orleans, LA
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3840 Corlear Avenue
New York, New York 10065
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New York, NY
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San Antonio, Texas
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San Antonio, TX
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San Diego, California
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San Diego, CA
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Shreveport, Louisiana
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Shreveport, LA
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