Erectile DysfunctionPhase 2NCT00282607
A Study of DA-8159 in Subjects With Erectile Dysfunction
A Phase 2 study testing DA-8159 in people with Erectile Dysfunction, run by Dong-A PharmTech Co., Ltd. at 15 sites in United States.
Trial summary
The purpose of this study will be to evaluate the clinical efficacy and safety of DA-8159, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of subjects with erectile dysfunction (ED). Read more about this study
- Who is it for?
- Ages 19 to 75 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- DA-8159
- How many people
- 300 participants
- Where
- 15 sitesUnited States
- Study dates
- May 2005to Jun 2006
- Phase
- Phase 2
- 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 19 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is male and at least 19 years of age.
- Has a stable monogamous relationship for at least 6 months with a consenting female partner (vaginal intercourse is a required study activity).
- Provides written informed consent.
- The subject's female partner provides written informed consent.
- Has a history of ED (clinically defined as the inability to attain and maintain an erection of the penis sufficient to permit satisfactory sexual intercourse) of at least 3 months duration. The investigator will record the etiology of the ED (organic, psychogenic or mixed).
- Has scored between 6-25 for the Erectile Function domain score (Questions Number 1-5, 15) at both Visits 1 \& 2.
- Completes least four diary entries by Visit 2, showing at least 4 attempts at sexual intercourse with a 50% or greater failure rate in achieving or in maintaining an erection sufficient to complete intercourse (defined as answering "no" to SEP questions #2 or #3).
- The subject's partner is not pregnant or lactating and both subject and partner agree to the use of a medically acceptable form of birth control. Exceptions would be subjects with a vasectomy or partners that are post menopausal, and partners that have had a tubal ligation or hysterectomy.
Who cannot join
- Has a history of stroke, myocardial infarction, or coronary artery disease within the past 6 months.
- Has a history of cardiac failure, angina, or life-threatening arrhythmia within the past 6 months.
- Is taking nitrate medication in any form(Appendix 7)
- Is taking alpha blockers.
- Has a clinically significant abnormal laboratory value as determined by the principal investigator.
- Has a history of uncontrolled diabetes (HbA1c>9%).
Show all 32Show fewer
- Has a history of proliferative diabetic retinopathy.
- Has a history of spinal cord injury or a radical prostatectomy or radical pelvic surgery.
- Has a supine blood pressure lower than 90/50mmHg or uncontrolled hypertension higher than 170/100mmHg.
- Has a anatomical deformity of the penis such as severe penile fibrosis or Peyronie's disease.
- Has a thyroid stimulating hormone (TSH) level lower than 30% of LLN.
- Has erectile dysfunction caused by neurological or endocrine factors such as hyperprolactinemia or low serum testosterone levels (<300 ng/dl).
- Has hepatic impairment (GOT, GPT levels > 3 x ULN).
- Has renal impairment (serum creatinine ≥ 2.5mg/dl).
- Has a history of hematological disorder such as bleeding disorder or a risk of GI bleeding such as peptic ulceration.
- Has a history of retinitis pigmentosa.
- Has a history of sickle cell disease, multiple myeloma, leukemia or any other disorders that may cause priapism.
- Has a history of significant psychiatric disorder.
- Has a history of central nervous system disorders such as stroke, transient ischemic attacks, or spinal cord injury.
- Has a history of drug abuse (alcohol, marijuana, cocaine, or opiates).
- Has a known sensitivity to drugs especially to phosphodiesterase type 5 inhibitors such as Viagra, Cialis or Levitra.
- Has used other erectile dysfunction therapies including nutraceutical and herbal products within 14 days prior to entering into this study.
- Is using concomitant medications that are known or suspected to interact with PDE 5 inhibitors such as the following:
- Antibacterial: erythromycin
- Antifungals: itraconazole, ketoconazole
- Antivirals: ritonavir, saquinavir, amprenavir, indinavir, nelfinavir
- H2 receptor antagonist: cimetidine
- Anticoagulants, androgens, trazodone
- Have other sexual disorders such as hypoactive sexual desire.
- Have previously failed to respond to PDE-5 inhibitors such as Viagra, Cialis or Levitra.
- Have a major illness that in the opinion of the investigator would interfere with the conduct of the study.
- Has not participated in a clinical drug study within the last 30 days prior to entering this study.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Urology Research Options
Aurora, Colorado, 80012
South Florida Medical Research
Aventura, Florida, 33180
The Male Clinic
Beverly Hills, California, 90212
Northeast Indiana Research, LLC
Fort Wayne, Indiana, 46825
Accumed Research Associates
Garden City, New York, 11530
Drs. Werner, Murdock & Francis, P.A. , Urology Associates
Greenbelt, Maryland, 20770
Medical Affiliated Research Center
Huntsville, Alabama, 35801
South Orange County
Laguna Woods, California, 92653
California Profession Research
Newport Beach, California, 92660
Florida Foundation for Healthcare Research
Ocala, Florida, 34474
University Urological Researcgh Institute
Providence, Rhode Island, 02904
Urology San Antonio Research
San Antonio, Texas, 78229
West Coast Clinical Research
Tarzana, California, 91356
Connecticut Clinical Research Center
Waterbury, Connecticut, 06708
Center for Urologic Research of Western New York
Williamsville, New York, 14221
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel Design Phase 2 Dose Ranging Trial To Assess The Safety and Efficacy of DA-8159 Tablets in Male Subjects With Erectile Dysfunction.
The purpose of this study will be to evaluate the clinical efficacy and safety of DA-8159, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of subjects with erectile dysfunction (ED).
Read the detailed description
This will be a multi-center, randomized, double-blind, placebo-controlled, parallel-group study in 300 erectile dysfunction patients. Patients will complete a screening visit (V1) to determine eligibility for the study based on the International Index of Erectile Function (IIEF) erectile function (EF) domain scores, patient history and safety measures. Patients that meet the entrance criteria for this study will enter a 4 week, drug-free run-in period to establish a baseline for the erectile function domain score and to meet the criteria for participation in the study.
Patients successfully completing screen will be randomly assigned to one of four treatment groups at Visit 2 (V2): placebo or one of 3 active drug doses of DA-8159 tablets. Patients will be given medication for at-home use and will also be given diaries for recording information regarding sexual encounters, quality of erections and adverse events. At 4-week intervals for 3 months (V3, V4, V5), patients will return to the clinic to review and collect SEP diaries, safety data, 12-lead ECG and medication reconciliation. In addition, at each 4-week interval patients will complete an IIEF, and at Visit 5 will have blood drawn for safety evaluation.
The primary efficacy end points are: a) the change in score (baseline to Visit 5) for the Erectile Function domain score of the IIEF, b) change in response, relative to baseline, for sexual encounter profile (SEP) question 2, and c) change in response, relative to baseline, for SEP question 3. For DA-8159 tablets to be judged efficacious, the DA-8159 tablet groups must be shown superior to the placebo group on all three measures.
- Conditions
- Erectile Dysfunction
- Being tested
- DA-8159
- Keywords
- Erectile Dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-8159Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy end points are:
the change in score (baseline to Visit 5) for the Erectile Function domain score of the IIEF;
change in response, relative to baseline, for sexual encounter profile (SEP) question 2, and
change in response, relative to baseline, for SEP question 3.
Safety will be assessed by monitoring adverse events and changes in vital signs, clinical laboratory test results, 12-lead ECG, and physical examinations.
Secondary outcomes (5)
The study has several secondary efficacy measurements including:
changes in the satisfaction of intercourse, orgasmic function, sexual desire and overall satisfaction domains of the IIEF,
changes from baseline in SEP questions 1, 4 and 5;
the global assessment questionnaire (GAQ), and
changes from baseline in patient self assessment questionnaire (PSAE) scores.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startMay 2005
- Study completionJun 2006
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Dong-A PharmTech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James L Yeager, RPh., Ph.D., Study directorHarin Padma-Nathan, MD, Principal investigator, The Male Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282607
- Sponsor's protocol ID
- DA 2005-001
- Status last verified
- Feb 2007
- First submitted
- 25 Jan 2006
- Last updated
- 28 Feb 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Parallel Design Phase 2 Dose Ranging Trial To Assess The Safety and Efficacy of DA-8159 Tablets in Male Subjects With Erectile Dysfunction.
- ClinicalTrials.gov ID
- NCT00282607
- Acronym / sponsor ID
- DA 2005-001
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Dong-A PharmTech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Jun 2006
- First posted
- 27 Jan 2006 (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 will be to evaluate the clinical efficacy and safety of DA-8159, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of subjects with erectile dysfunction (ED).
Detailed description
This will be a multi-center, randomized, double-blind, placebo-controlled, parallel-group study in 300 erectile dysfunction patients. Patients will complete a screening visit (V1) to determine eligibility for the study based on the International Index of Erectile Function (IIEF) erectile function (EF) domain scores, patient history and safety measures. Patients that meet the entrance criteria for this study will enter a 4 week, drug-free run-in period to establish a baseline for the erectile function domain score and to meet the criteria for participation in the study.
Patients successfully completing screen will be randomly assigned to one of four treatment groups at Visit 2 (V2): placebo or one of 3 active drug doses of DA-8159 tablets. Patients will be given medication for at-home use and will also be given diaries for recording information regarding sexual encounters, quality of erections and adverse events. At 4-week intervals for 3 months (V3, V4, V5), patients will return to the clinic to review and collect SEP diaries, safety data, 12-lead ECG and medication reconciliation. In addition, at each 4-week interval patients will complete an IIEF, and at Visit 5 will have blood drawn for safety evaluation.
The primary efficacy end points are: a) the change in score (baseline to Visit 5) for the Erectile Function domain score of the IIEF, b) change in response, relative to baseline, for sexual encounter profile (SEP) question 2, and c) change in response, relative to baseline, for SEP question 3. For DA-8159 tablets to be judged efficacious, the DA-8159 tablet groups must be shown superior to the placebo group on all three measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 19 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Is male and at least 19 years of age.
- Has a stable monogamous relationship for at least 6 months with a consenting female partner (vaginal intercourse is a required study activity).
- Provides written informed consent.
- The subject's female partner provides written informed consent.
- Has a history of ED (clinically defined as the inability to attain and maintain an erection of the penis sufficient to permit satisfactory sexual intercourse) of at least 3 months duration. The investigator will record the etiology of the ED (organic, psychogenic or mixed).
Key exclusion criteria (32 listed)
- Has a history of stroke, myocardial infarction, or coronary artery disease within the past 6 months.
- Has a history of cardiac failure, angina, or life-threatening arrhythmia within the past 6 months.
- Is taking nitrate medication in any form(Appendix 7)
- Is taking alpha blockers.
- Has a clinically significant abnormal laboratory value as determined by the principal investigator.
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 |
|---|---|---|
| DA-8159 | Drug | – |
Primary outcome
The primary efficacy end points are:
the change in score (baseline to Visit 5) for the Erectile Function domain score of the IIEF;
change in response, relative to baseline, for sexual encounter profile (SEP) question 2, and
change in response, relative to baseline, for SEP question 3.
Safety will be assessed by monitoring adverse events and changes in vital signs, clinical laboratory test results, 12-lead ECG, and physical examinations.
5 secondary outcomes
The study has several secondary efficacy measurements including:
changes in the satisfaction of intercourse, orgasmic function, sexual desire and overall satisfaction domains of the IIEF,
changes from baseline in SEP questions 1, 4 and 5;
the global assessment questionnaire (GAQ), and
changes from baseline in patient self assessment questionnaire (PSAE) scores.
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 28 Feb 2007.
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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.
James L Yeager, RPh., Ph.D. study director
Harin Padma-Nathan, MD principal investigator
The Male Clinic
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DA-8159 in people with Erectile Dysfunction, run by Dong-A PharmTech Co., Ltd. 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 8 inclusion and 32 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 28 Feb 2007. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 primary efficacy end points are:. The study lists 5 primary outcomes in all. 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 28 Feb 2007.