Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
VIVUS LLC
Age
18–45
Sex
MALE
Healthy volunteers
Accepted
You may be eligible 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 be 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.
Clareo Health | Study Evaluating the Effects of Avanafil on Semen Parameters
