Study Evaluating the Effects of Avanafil on Semen Parameters
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
1 other identifier
interventional
181
1 country
15
Brief Summary
The purpose of this study is to determine whether avanafil will affect different aspects of sperm production.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2012
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 11, 2013
CompletedFirst Posted
Study publicly available on registry
January 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
December 14, 2015
CompletedDecember 14, 2015
November 1, 2015
1.7 years
January 11, 2013
October 7, 2015
November 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Count From Baseline to Week 26
baseline to week 26
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Motility From Baseline to Week 26
baseline to week 26
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Semen Volume From Baseline to Week 26
baseline to week 26
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Normal Sperm Morphology From Baseline to Week 26
baseline to week 26
Study Arms (2)
avanafil
EXPERIMENTAL100 mg
Placebo
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VIVUS LLClead
Study Sites (15)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wesley D Day, PhD
- Organization
- Vivus
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2013
First Posted
January 15, 2013
Study Start
December 1, 2012
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
December 14, 2015
Results First Posted
December 14, 2015
Record last verified: 2015-11