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Study Evaluating the Effects of Avanafil on Semen Parameters

This study has been completed.
Information provided by (Responsible Party):
VIVUS, Inc. Identifier:
First received: January 11, 2013
Last updated: November 5, 2015
Last verified: November 2015
The purpose of this study is to determine whether avanafil will affect different aspects of sperm production.

Condition Intervention Phase
Erectile Dysfunction Drug: avanafil Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:
  • Percentage of Subjects With a Greater Than or Equal to 50% Decrease in Sperm Concentration From Baseline to Week 26 [ Time Frame: 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.

Secondary Outcome Measures:
  • Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Count From Baseline to Week 26 [ Time Frame: baseline to week 26 ]
  • Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Motility From Baseline to Week 26 [ Time Frame: baseline to week 26 ]
    Sperm motility was based upon the WHO grading scale: grade A, B, or C.

  • Percentage of Subjects With Greater Than or Equal to 50% Reduction in Semen Volume From Baseline to Week 26 [ Time Frame: baseline to week 26 ]
  • Percentage of Subjects With Greater Than or Equal to 50% Reduction in Normal Sperm Morphology From Baseline to Week 26 [ Time Frame: baseline to week 26 ]

Enrollment: 181
Study Start Date: December 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: avanafil
100 mg
Drug: avanafil
100 mg
Other Names:
  • TA-1790
  • Stendra
Placebo Comparator: Placebo
Drug: Placebo


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01768676

United States, Alabama
Research Facility
Huntsville, Alabama, United States
United States, California
Research Facility
LA, California, United States
Research Facility
San Diego, California, United States
United States, Colorado
Research Facility
Parker, Colorado, United States
United States, Florida
Research Facility
Aventura, Florida, United States
United States, Indiana
Research Facility
Carmel, Indiana, United States
United States, Louisiana
Research Facility
New Orleans, Louisiana, United States
Research Facility
Shreveport, Louisiana, United States
United States, Missouri
Research Facility
Kansas City, Missouri, United States
United States, New York
Research Facility
Albany, New York, United States
Research Facility
New York, New York, United States
United States, Ohio
Research Facility
Cincinnati, Ohio, United States
United States, Pennsylvania
Research Facility
Bala Cynwyd, Pennsylvania, United States
United States, Tennessee
Research Facility
Knoxville, Tennessee, United States
United States, Texas
Research Facility
San Antonio, Texas, United States
Sponsors and Collaborators
  More Information

Responsible Party: VIVUS, Inc. Identifier: NCT01768676     History of Changes
Other Study ID Numbers: TA-401
Study First Received: January 11, 2013
Results First Received: October 7, 2015
Last Updated: November 5, 2015

Keywords provided by VIVUS, Inc.:
healthy male

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders processed this record on August 23, 2017