Study Evaluating the Effects of Avanafil on Semen Parameters

Completed · Phase 4 · Has a placebo group

Conditions studied: Erectile Dysfunction

In brief

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

Key facts

Study ID

NCT01768676

Run by

VIVUS LLC

People needed

181

Starts

2012-12-01

Expected to finish

2014-08-01

Last updated by the study team

2015-12-14

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Facility — Huntsville, Alabama, United States
• Research Facility — Los Angeles, California, United States
• Research Facility — San Diego, California, United States
• Research Facility — Parker, Colorado, United States
• Research Facility — Aventura, Florida, United States
• Research Facility — Carmel, Indiana, United States
• Research Facility — New Orleans, Louisiana, United States
• Research Facility — Shreveport, Louisiana, United States
• Research Facility — Kansas City, Missouri, United States
• Research Facility — Albany, New York, United States
• Research Facility — New York, New York, United States
• Research Facility — Cincinnati, Ohio, United States
• Research Facility — Bala-Cynwyd, Pennsylvania, United States
• Research Facility — Knoxville, Tennessee, United States
• Research Facility — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.