Study Evaluating the Effects of Avanafil on Semen Parameters

Vivus

Status and phase

Completed

Phase 4

Conditions

Erectile Dysfunction

Treatments

Drug: Placebo

Drug: avanafil

Study type

Interventional

Funder types

Industry

Identifiers

TA-401

Details and patient eligibility

About

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

Enrollment

181 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.