Study Evaluating the Effects of Avanafil on Semen Parameters

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT01768676
First received: January 11, 2013
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 220
Study Start Date: December 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: February 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
placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
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 ClinicalTrials.gov identifier: NCT01768676

Locations
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, Inc.
  More Information

No publications provided

Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT01768676     History of Changes
Other Study ID Numbers: TA-401
Study First Received: January 11, 2013
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:
healthy male

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014