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Study Evaluating the Effects of Avanafil on Semen Parameters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01768676
Recruitment Status : Completed
First Posted : January 15, 2013
Results First Posted : December 14, 2015
Last Update Posted : December 14, 2015
Sponsor:
Information provided by (Responsible Party):
VIVUS LLC

Study Description
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Brief Summary:
The purpose of this study is to determine whether avanafil will affect different aspects of sperm production.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: avanafil Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
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
Study Start Date : December 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Avanafil

Arms and Interventions
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Arm Intervention/treatment
Experimental: avanafil
100 mg
 Drug: avanafil
100 mg
Other Names:
  • TA-1790
  • Stendra
Placebo Comparator: Placebo
placebo
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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.

  3. 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 ]
  4. 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 ]

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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768676


Locations
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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
VIVUS LLC
More Information
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Responsible Party: VIVUS LLC
ClinicalTrials.gov Identifier: NCT01768676    
Other Study ID Numbers: TA-401
First Posted: January 15, 2013    Key Record Dates
Results First Posted: December 14, 2015
Last Update Posted: December 14, 2015
Last Verified: November 2015
Keywords provided by VIVUS LLC:
healthy male
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders