Erectile DysfunctionPhase 1NCT01100021
Hemodynamic Study of Avanafil and Two α-Adrenergic Blockers,Doxazosin and Tamsulosin
A Phase 1 study testing Tamsulosin and avanafil and Doxazosin and avanafil in people with Erectile Dysfunction, run by VIVUS LLC at 1 site in United States.
Trial summary
The purpose of this study is to see if avanafil causes any changes in blood pressure and pulse rate when taken with doxazosin or tamsulosin. Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Tamsulosin and avanafil and Doxazosin and avanafil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written Informed Consent.
- Adult male subjects 40 to 65 years of age, inclusive.
- A body weight of at least 50 kg and a body mass index (BMI) between 18 and 32 kg/m2, inclusive [BMI will be calculated as weight in kg/(height in m)2].
- Subjects are able to communicate with the Investigator, and to understand and comply with all requirements of study participation.
- Medically healthy, with no clinically significant screening results (e.g., laboratory profiles, medical histories, ECGs, physical exam, etc.), in the opinion of the Investigator in consultation with the Sponsor.
- Male subjects should be willing to use a condom and spermicide during sexual activity for 90 days after last dosing of avanafil and be willing to not donate sperm for 90 days after dosing.
Who cannot join
- A history or presence of significant cardiovascular (including thromboembolic disorders), neurological, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs or place the subjects at increased risk as determined by the Investigator.
- Any clinically significant laboratory abnormalities as judged by the Investigator. Inclusion of a subject with out of normal range laboratory values must be approved by VIVUS prior to subject enrollment.
- A predisposition to priapism, such as subjects with sickle cell disease or blood dyscrasias.
- Known history of cardiovascular or cerebrovascular event, any history of angina.
- Subjects with episode(s) of fainting or vasovagal hypotension.
- History or ECG evidence of any high-risk arrhythmia or ECG judged by the Investigator to be clinically significant.
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- Hypertrophic obstructive or other clinically significant cardiomyopathy, moderate or severe cardiac valvular disease.
- Subjects whose pulse is lower than 55 bpm at screening or 50 bpm prior to dosing.
- Acute illness, especially any infection, within 2 weeks of dosing.
- Systolic blood pressure < 90 or >150 mmHg; diastolic blood pressure < 50 or > 95 mmHg at screening or at check-in on Day -1 (2 rechecks are allowed).
- Subjects with benign prostatic hyperplasia or orthostatic hypotension (as evidenced by reduction of 20 mmHg or more in systolic blood pressure, reduction of 10 mmHg or more in diastolic blood pressure, or evidence of cerebral hypoperfusion upon standing from a seated position).
- History of retinitis pigmentosa or nonarteritic anterior ischemic optic neuropathy.
- Any history of bipolar disorder or psychosis, history of psychiatric hospitalization, greater than one lifetime episode of major depression.
- Hemoglobin < 12.0 g/dL.
- Subjects with liver function tests > 1.5 ULN
- Positive urine drug test and/or positive urine alcohol test at screening or at check-in on Day -1.
- Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV) at screening.
- Any history or presence of alcoholism or drug or substance abuse within 18 months or as defined by the Investigator.
- Allergy to or previously significant adverse events with PDE5 inhibitors, doxazosin and tamsulosin or their constituents.
- Use of any prescription or over-the-counter (OTC) medication, including herbal products, within the 14 days prior to Day 1. Up to 2 g per day of acetaminophen is allowed at the discretion of the Investigator.
- Use of any drug in Appendix 1 (drugs known to have clinical significance in inhibiting or inducing liver enzymes involved in drug metabolism [CYP P450]) within 30 days prior to Day 1.
- Blood donation or significant blood loss within 56 days prior to Day 1.
- Plasma donation within 14 days prior to Day 1.
- Any use of tobacco or nicotine products within 6 months prior to Day 1. Serum cotinine levels <10 ng/mL are considered to be consistent with no active smoking.
- Any subject who received an investigational drug within 30 days or six half-lives, whichever is longer, prior to Day 1.
- Evidence of any clinically significant medical, psychiatric, social or other condition by history, physical examination or laboratory studies that, in the opinion of the Investigator, would contraindicate the administration of study medications, affect compliance, interfere with study evaluations, limit study participation, or confound the interpretation of study results.
- Involvement in the planning and conduct of the study (applies to both VIVUS or designee staff, or staff at the investigational site).
- Previously participated in a trial with avanafil.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-centre, Double-blind, Randomized, Placebo-controlled, Two-cohort, Two-period Crossover Study of the Hemodynamic Interactions Between Avanafil and Two α-Adrenergic Blockers, Doxazosin and Tamsulosin, in Middle-aged Healthy Male Subjects
The purpose of this study is to see if avanafil causes any changes in blood pressure and pulse rate when taken with doxazosin or tamsulosin.
- Conditions
- Erectile Dysfunction
- Being tested
- Tamsulosin and avanafil, Doxazosin and avanafil
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin and avanafilDrug
tamsulosin - 0.4mg daily for 18 days; avanafil - 200 mg 1 x 2 days
Doxazosin and avanafilDrug
doxazosin - 1 mg 1 x 1 day; 2 mg 1 x 2 days; 4 mg 1 x 4 days; 8 mg 1 x 11 days; avanafil - 200 mg 1 x 1 day
| Study group | Role | What they receive |
|---|---|---|
| tamsulosin + avanafil | Experimental | Not described Receives: Drug: Tamsulosin and avanafil |
| Doxazosin + avanafil | Experimental | Not described Receives: Drug: Doxazosin and avanafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum decrease in blood pressure after dosing
Measured: 30, 20, 10 min predose; 15, 30, 45, 60, 75, 90, 105, 120 min, 2.5, 3, 3.5, 4, 5, 6, 7, 10, 12, 18, and 24 hrs postdose
Secondary outcomes (1)
The maximum decrease in blood pressure and pulse rate after dosing
Measured: 30, 20, 10 min predose; 15, 30, 45, 60, 75, 90, 105, 120 min, 2.5, 3, 3.5, 4, 5, 6, 7, 10, 12, 18, and 24 hrs postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVUS LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scott Sharples, MD, Principal investigator, MDS Pharma Services, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100021
- Sponsor's protocol ID
- TA-017
- Status last verified
- Jan 2011
- First submitted
- 20 Jan 2010
- Last updated
- 7 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-centre, Double-blind, Randomized, Placebo-controlled, Two-cohort, Two-period Crossover Study of the Hemodynamic Interactions Between Avanafil and Two α-Adrenergic Blockers, Doxazosin and Tamsulosin, in Middle-aged Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01100021
- Acronym / sponsor ID
- TA-017
- Conditions
- Erectile Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- VIVUS LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 8 Apr 2010 (estimated)
- Results
- Not posted in the source record
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 see if avanafil causes any changes in blood pressure and pulse rate when taken with doxazosin or tamsulosin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tamsulosin + avanafil | Experimental | Drug: Tamsulosin and avanafil |
| Doxazosin + avanafil | Experimental | Drug: Doxazosin and avanafil |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written Informed Consent.
- Adult male subjects 40 to 65 years of age, inclusive.
- A body weight of at least 50 kg and a body mass index (BMI) between 18 and 32 kg/m2, inclusive [BMI will be calculated as weight in kg/(height in m)2].
- Subjects are able to communicate with the Investigator, and to understand and comply with all requirements of study participation.
- Medically healthy, with no clinically significant screening results (e.g., laboratory profiles, medical histories, ECGs, physical exam, etc.), in the opinion of the Investigator in consultation with the Sponsor.
Key exclusion criteria (28 listed)
- A history or presence of significant cardiovascular (including thromboembolic disorders), neurological, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs or place the subjects at increased risk as determined by the Investigator.
- Any clinically significant laboratory abnormalities as judged by the Investigator. Inclusion of a subject with out of normal range laboratory values must be approved by VIVUS prior to subject enrollment.
- A predisposition to priapism, such as subjects with sickle cell disease or blood dyscrasias.
- Known history of cardiovascular or cerebrovascular event, any history of angina.
- Subjects with episode(s) of fainting or vasovagal hypotension.
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 |
|---|---|---|
| Tamsulosin and avanafiltamsulosin - 0.4mg daily for 18 days; avanafil - 200 mg 1 x 2 days | Drug | tamsulosin + avanafil |
| Doxazosin and avanafildoxazosin - 1 mg 1 x 1 day; 2 mg 1 x 2 days; 4 mg 1 x 4 days; 8 mg 1 x 11 days; avanafil - 200 mg 1 x 1 day | Drug | Doxazosin + avanafil |
Primary outcome
The maximum decrease in blood pressure after dosing
Time frame: 30, 20, 10 min predose; 15, 30, 45, 60, 75, 90, 105, 120 min, 2.5, 3, 3.5, 4, 5, 6, 7, 10, 12, 18, and 24 hrs postdose
1 secondary outcome
The maximum decrease in blood pressure and pulse rate after dosing
Time frame: 30, 20, 10 min predose; 15, 30, 45, 60, 75, 90, 105, 120 min, 2.5, 3, 3.5, 4, 5, 6, 7, 10, 12, 18, and 24 hrs postdose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2011.
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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.
Scott Sharples, MD principal investigator
MDS Pharma Services, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tamsulosin and avanafil and Doxazosin and avanafil in people with Erectile Dysfunction, run by VIVUS LLC at 1 site 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 6 inclusion and 28 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 7 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The maximum decrease in blood pressure after dosing (time frame: 30, 20, 10 min predose; 15, 30, 45, 60, 75, 90, 105, 120 min, 2.5, 3, 3.5, 4, 5, 6, 7, 10, 12, 18, and 24 hrs postdose). 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 7 Jan 2011.