Erectile Dysfunction Clinical Trial
Official title:
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
Verified date | November 2015 |
Source | VIVUS, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine whether avanafil will affect different aspects of sperm production.
Status | Completed |
Enrollment | 181 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Research Facility | Albany | New York |
United States | Research Facility | Aventura | Florida |
United States | Research Facility | Bala Cynwyd | Pennsylvania |
United States | Research Facility | Carmel | Indiana |
United States | Research Facility | Cincinnati | Ohio |
United States | Research Facility | Huntsville | Alabama |
United States | Research Facility | Kansas City | Missouri |
United States | Research Facility | Knoxville | Tennessee |
United States | Research Facility | LA | California |
United States | Research Facility | New Orleans | Louisiana |
United States | Research Facility | New York | New York |
United States | Research Facility | Parker | Colorado |
United States | Research Facility | San Antonio | Texas |
United States | Research Facility | San Diego | California |
United States | Research Facility | Shreveport | Louisiana |
Lead Sponsor | Collaborator |
---|---|
VIVUS, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Subjects With a Greater Than or Equal to 50% Decrease in Sperm Concentration From Baseline to Week 26 | Subjects provided 2 semen samples at each visit 2 to 12 days apart. The average value is used as the visit result. | Baseline to Week 26 | Yes |
Secondary | Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Count From Baseline to Week 26 | baseline to week 26 | Yes | |
Secondary | Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Motility From Baseline to Week 26 | Sperm motility was based upon the WHO grading scale: grade A, B, or C. | baseline to week 26 | Yes |
Secondary | Percentage of Subjects With Greater Than or Equal to 50% Reduction in Semen Volume From Baseline to Week 26 | baseline to week 26 | Yes | |
Secondary | Percentage of Subjects With Greater Than or Equal to 50% Reduction in Normal Sperm Morphology From Baseline to Week 26 | baseline to week 26 | Yes |
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