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Study Evaluating the Effects of Avanafil on Semen Parameters

NCT ID: NCT01768676

Last Updated: 2015-12-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-08-31

Brief Summary

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

Detailed Description

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Conditions

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Erectile Dysfunction

Keywords

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healthy male

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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avanafil

100 mg

Group Type EXPERIMENTAL

avanafil

Intervention Type DRUG

100 mg

Placebo

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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avanafil

100 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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TA-1790 Stendra

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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VIVUS LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Facility

Huntsville, Alabama, United States

Site Status

Research Facility

Los Angeles, California, United States

Site Status

Research Facility

San Diego, California, United States

Site Status

Research Facility

Parker, Colorado, United States

Site Status

Research Facility

Aventura, Florida, United States

Site Status

Research Facility

Carmel, Indiana, United States

Site Status

Research Facility

New Orleans, Louisiana, United States

Site Status

Research Facility

Shreveport, Louisiana, United States

Site Status

Research Facility

Kansas City, Missouri, United States

Site Status

Research Facility

Albany, New York, United States

Site Status

Research Facility

New York, New York, United States

Site Status

Research Facility

Cincinnati, Ohio, United States

Site Status

Research Facility

Bala-Cynwyd, Pennsylvania, United States

Site Status

Research Facility

Knoxville, Tennessee, United States

Site Status

Research Facility

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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TA-401

Identifier Type: -

Identifier Source: org_study_id