Clinical trial NCT01768676: Study Evaluating the Effects of Avanafil on Semen Parameters
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: healthy male
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
First posted: 2013-01-15
Enrollment: 181
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Percentage of Subjects With a Greater Than or Equal to 50% Decrease in Sperm Concentration From Baseline to Week 26
timeFrame: Baseline to Week 26
Secondary outcomes:
measure: Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Count From Baseline to Week 26
timeFrame: baseline to week 26
measure: Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Motility From Baseline to Week 26
timeFrame: baseline to week 26
measure: Percentage of Subjects With Greater Than or Equal to 50% Reduction in Semen Volume From Baseline to Week 26
timeFrame: baseline to week 26
measure: Percentage of Subjects With Greater Than or Equal to 50% Reduction in Normal Sperm Morphology From Baseline to Week 26
timeFrame: baseline to week 26
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Facility
state: Alabama
city: LA
country: United States
facility: Research Facility
state: California
city: San Diego
country: United States
facility: Research Facility
state: California
city: Parker
country: United States
facility: Research Facility
state: Colorado
city: Aventura
country: United States
facility: Research Facility
state: Florida
city: Carmel
country: United States
facility: Research Facility
state: Indiana
city: New Orleans
country: United States
facility: Research Facility
state: Louisiana
city: Shreveport
country: United States
facility: Research Facility
state: Louisiana
city: Kansas City
country: United States
facility: Research Facility
state: Missouri
city: Albany
country: United States
facility: Research Facility
state: New York
city: New York
country: United States
facility: Research Facility
state: New York
city: Cincinnati
country: United States
facility: Research Facility
state: Ohio
city: Bala Cynwyd
country: United States
facility: Research Facility
state: Pennsylvania
city: Knoxville
country: United States
facility: Research Facility
state: Tennessee
city: San Antonio
country: United States
facility: Research Facility
state: Texas
Study officials:
References: