A Study of DA-8159 in Subjects With Erectile Dysfunction
NCT ID: NCT00282607
Last Updated: 2007-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
300 participants
INTERVENTIONAL
2005-05-31
2006-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DA-8159
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Has a stable monogamous relationship for at least 6 months with a consenting female partner (vaginal intercourse is a required study activity).
3. Provides written informed consent.
4. The subject's female partner provides written informed consent.
5. 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).
6. Has scored between 6-25 for the Erectile Function domain score (Questions Number 1-5, 15) at both Visits 1 \& 2.
7. 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).
8. 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.
Exclusion Criteria
2. Has a history of cardiac failure, angina, or life-threatening arrhythmia within the past 6 months.
3. Is taking nitrate medication in any form(Appendix 7)
4. Is taking alpha blockers.
5. Has a clinically significant abnormal laboratory value as determined by the principal investigator.
6. Has a history of uncontrolled diabetes (HbA1c\>9%).
7. Has a history of proliferative diabetic retinopathy.
8. Has a history of spinal cord injury or a radical prostatectomy or radical pelvic surgery.
9. Has a supine blood pressure lower than 90/50mmHg or uncontrolled hypertension higher than 170/100mmHg.
10. Has a anatomical deformity of the penis such as severe penile fibrosis or Peyronie's disease.
11. Has a thyroid stimulating hormone (TSH) level lower than 30% of LLN.
12. Has erectile dysfunction caused by neurological or endocrine factors such as hyperprolactinemia or low serum testosterone levels (\<300 ng/dl).
13. Has hepatic impairment (GOT, GPT levels \> 3 x ULN).
14. Has renal impairment (serum creatinine ≥ 2.5mg/dl).
15. Has a history of hematological disorder such as bleeding disorder or a risk of GI bleeding such as peptic ulceration.
16. Has a history of retinitis pigmentosa.
17. Has a history of sickle cell disease, multiple myeloma, leukemia or any other disorders that may cause priapism.
18. Has a history of significant psychiatric disorder.
19. Has a history of central nervous system disorders such as stroke, transient ischemic attacks, or spinal cord injury.
20. Has a history of drug abuse (alcohol, marijuana, cocaine, or opiates).
21. Has a known sensitivity to drugs especially to phosphodiesterase type 5 inhibitors such as Viagra, Cialis or Levitra.
22. Has used other erectile dysfunction therapies including nutraceutical and herbal products within 14 days prior to entering into this study.
23. Is using concomitant medications that are known or suspected to interact with PDE 5 inhibitors such as the following:
1. Antibacterial: erythromycin
2. Antifungals: itraconazole, ketoconazole
3. Antivirals: ritonavir, saquinavir, amprenavir, indinavir, nelfinavir
4. H2 receptor antagonist: cimetidine
5. Anticoagulants, androgens, trazodone
24. Have other sexual disorders such as hypoactive sexual desire.
25. Have previously failed to respond to PDE-5 inhibitors such as Viagra, Cialis or Levitra.
26. Have a major illness that in the opinion of the investigator would interfere with the conduct of the study.
27. Has not participated in a clinical drug study within the last 30 days prior to entering this study.
19 Years
75 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dong-A PharmTech Co., Ltd.
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James L Yeager, RPh., Ph.D.
Role: STUDY_DIRECTOR
Harin Padma-Nathan, MD
Role: PRINCIPAL_INVESTIGATOR
The Male Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical Affiliated Research Center
Huntsville, Alabama, United States
The Male Clinic
Beverly Hills, California, United States
South Orange County
Laguna Woods, California, United States
California Profession Research
Newport Beach, California, United States
West Coast Clinical Research
Tarzana, California, United States
Urology Research Options
Aurora, Colorado, United States
Connecticut Clinical Research Center
Waterbury, Connecticut, United States
South Florida Medical Research
Aventura, Florida, United States
Florida Foundation for Healthcare Research
Ocala, Florida, United States
Northeast Indiana Research, LLC
Fort Wayne, Indiana, United States
Drs. Werner, Murdock & Francis, P.A. , Urology Associates
Greenbelt, Maryland, United States
Accumed Research Associates
Garden City, New York, United States
Center for Urologic Research of Western New York
Williamsville, New York, United States
University Urological Researcgh Institute
Providence, Rhode Island, United States
Urology San Antonio Research
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DA 2005-001
Identifier Type: -
Identifier Source: org_study_id