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| Sponsor: | Biovail Laboratories International SRL |
|---|---|
| Information provided by: | Biovail Laboratories International SRL |
| ClinicalTrials.gov Identifier: | NCT00983151 |
Purpose
The purpose of this clinical trial is to test an experimental drug therapy, which contains a medication called Tramadol Hydrochloride (HCl) Orally Disintegrating Tablets (ODT) ("Tramadol HC1 ODT" or the "study drug"). The subject and their partner are being asked to be in this clinical trial because they have a condition called premature ejaculation.
| Condition | Intervention | Phase |
|---|---|---|
|
Premature Ejaculation |
Drug: Tramadol Hydrochloride & Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Two Doses of Tramadol Hydrochloride Orally Disintegrating Tablets in Male Subjects With Premature Ejaculation |
| Estimated Enrollment: | 1050 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active: Experimental |
Drug: Tramadol Hydrochloride & Placebo
89 mg or a lesser dose of 62 mg if side effects are experienced one tablet at least two hours before sexual intercourse (maximum of one tablet every 20 hours) Subject will take the study drug for about 27 weeks
|
| Placebo: Placebo Comparator |
Drug: Tramadol Hydrochloride & Placebo
89 mg or a lesser dose of 62 mg if side effects are experienced one tablet at least two hours before sexual intercourse (maximum of one tablet every 20 hours) Subject will take the study drug for about 27 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects are eligible for study participation if all of the following criteria are met:
History of premature or rapid ejaculation, determined by following criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV TR):
Exclusion Criteria:
Subjects are not eligible for study participation if any of the following criteria are met:
Other sexual dysfunction:
i.Erectile dysfunction. As defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV TR), the diagnostic criteria for male erectile disorder (302,72) erectile dysfunction includes:
A.Persistent or recurrent inability to attain, or to maintain until completion of the sexual activity, an adequate erection.
B.The disturbance causes marked distress or interpersonal difficulty. ii.Primary reduced sexual desire unrelated to premature ejaculation
Use of medication, within the preceding 30 days, with potential to cause sexual dysfunction: (See Appendix 2 for a list of excluded medications) i.Antidepressants - all types
ii.Antipsychotic medication
iii.Antihypertensive medication, unless on a stable dose > 6 months
iv.Hormonal drugs
v.Chemotherapy
vi.Others: cimetidine, clofibrate,quinidine
Contacts and Locations| Belgium | |
| Hubert Claes, MD | Recruiting |
| Bruxelles, Belgium | |
| Contact: Claes hubert.claes@scarlet.be | |
| Principal Investigator: | Hubert Claes, MD | Clinique St Jean |
More Information
| Responsible Party: | Michael Sparozic ( Biovail Laboratories International SRL ) |
| Study ID Numbers: | BVF-324-301 |
| Study First Received: | September 22, 2009 |
| Last Updated: | November 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00983151 History of Changes |
| Health Authority: | Austria: Federal Office for Safety in Health Care; Belgium: Federal Agency for Medicinal Products and Health Products; France: Ministry of Health; Germany: Ministry of Health; Italy: Ethics Committee; Netherlands: Independent Ethics Committee; Spain: Ethics Committee; Sweden: Regional Ethical Review Board; United Kingdom: Research Ethics Committee |
|
Sexual Dysfunctions, Psychological Tramadol Physiological Effects of Drugs Central Nervous System Depressants Narcotics Sexual and Gender Disorders Pharmacologic Actions |
Mental Disorders Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |