Erectile DysfunctionPhase 4NCT01768676
Study Evaluating the Effects of Avanafil on Semen Parameters
A Phase 4 study testing avanafil in people with Erectile Dysfunction, run by VIVUS LLC at 15 sites in United States.
Trial summary
The purpose of this study is to determine whether avanafil will affect different aspects of sperm production. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- avanafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 15 sitesUnited States
- Study dates
- Dec 2012to Aug 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Research Facility
Albany, New York
Research Facility
Aventura, Florida
Research Facility
Bala-Cynwyd, Pennsylvania
Research Facility
Carmel, Indiana
Research Facility
Cincinnati, Ohio
Research Facility
Huntsville, Alabama
Research Facility
Kansas City, Missouri
Research Facility
Knoxville, Tennessee
Research Facility
Los Angeles, California
Research Facility
New Orleans, Louisiana
Research Facility
New York, New York
Research Facility
Parker, Colorado
Research Facility
San Antonio, Texas
Research Facility
San Diego, California
Research Facility
Shreveport, Louisiana
About this study
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
The purpose of this study is to determine whether avanafil will affect different aspects of sperm production.
- Conditions
- Erectile Dysfunction
- Being tested
- avanafil, Placebo
- Keywords
- healthy male
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
avanafilDrug
Also called TA-1790, Stendra
100 mg
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| avanafil | Experimental | 100 mg Receives: Drug: avanafil |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With a Greater Than or Equal to 50% Decrease in Sperm Concentration From 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.
Measured: Baseline to Week 26
Secondary outcomes (4)
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Count From Baseline to Week 26
Measured: baseline to week 26
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Sperm Motility From Baseline to Week 26
Sperm motility was based upon the WHO grading scale: grade A, B, or C.
Measured: baseline to week 26
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Semen Volume From Baseline to Week 26
Measured: baseline to week 26
Percentage of Subjects With Greater Than or Equal to 50% Reduction in Normal Sperm Morphology From Baseline to Week 26
Measured: baseline to week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVUS LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768676
- Sponsor's protocol ID
- TA-401
- Status last verified
- Nov 2015
- First submitted
- 11 Jan 2013
- Last updated
- 14 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01768676
- Acronym / sponsor ID
- TA-401
- Conditions
- Erectile Dysfunction
- Keywords
- healthy male
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- VIVUS LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 15 Jan 2013 (estimated)
- Results
- Posted 14 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether avanafil will affect different aspects of sperm production.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| avanafil | Experimental | Drug: avanafil100 mg |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| avanafilAlso: TA-1790, Stendra100 mg | Drug | avanafil |
| Placebo | Drug | Placebo |
Primary outcome
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.
4 secondary outcomes
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Erectile Dysfunction
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction
RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Active, not recruiting
Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.
Pudendal Nerve Injury, Erectile Dysfunction
Active, not recruiting
Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction
Erectile Dysfunction, Electric Stimulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing avanafil in people with Erectile Dysfunction, run by VIVUS LLC at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.