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.
- Conditions
- Premature EjaculationMedDRA version: 9.1Level: LLTClassification code 10036596Term: Premature ejaculation
- Registration Number
- EUCTR2009-011410-18-FR
- Lead Sponsor
- Biovail Laboratories International SRL, c/o Biovail Technologies Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1050
Subjects are eligible for study participation if all of the following criteria are met:
1. Subject and partner to provide written informed consent prior to the performance of any study-specific procedures;
2. Candidates will be male subjects aged 18-65 years inclusive, with lifelong premature ejaculation
3. History of premature or rapid ejaculation, with the following criteria in accordance with the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV):
a) Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after vaginal insertion and before the person wishes it, taking into account factors that affect duration of the excitement phase such as age, novelty of the sexual partner or situation and recent frequency of sexual activity
b) The disturbance causes marked distress or interpersonal difficulty
c) The premature ejaculation is not due exclusively to the direct effects of a substance (ab)use
4. In a stable, monogamous, heterosexual relationship (> 6 months).
5. Willing and able to take study medication as directed at least 2 hours prior to sexual intercourse according to protocol;
6. Subject willing and able to complete the therapeutic trial, all sexual behavior logs, IELT assessments, questionnaires and interviews:
7. Female sexual partner willing and able to complete the therapeutic trial, all sexual behavior logs, IELT assessments, questionnaires and interviews;
8. Able to understand the study procedures, complete the assessments, and communicate with study personnel;
9. Subject and partner willing and able to attempt vaginal intercourse at least three times between visits to yield at least three successful events per 3-week period;
10. Subject and partner willing to use a reliable contraceptive method during the trial period, if the partner is not menopausal;
11. Partner willing to take pregnancy test prior to participation;
12. Subject willing to list and document prescription and non-prescription drug use during the study;
13. Have a negative urine drug screen at screening and baseline;
14. Be in good general health as determined by medical history and physical examination and expected by the investigator to complete the study as designed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects are not eligible for study participation if any of the following criteria are met:
1. Ejaculation attributable to situational or relationship issues;
2. Evidence or a history of other significant psychiatric disorder requiring therapy or medication;
3. Subjects who in the investigator’s opinion are at significant risk of suicide.
4. Physical illnesses
i. History of seizures, Prostatitis (current), Urethritis or other urinary tract infections (current), Prior genital surgery (other than vasectomy or circumcision), Uncontrolled Diabetes mellitus, Respiratory Depression, Thyroid disease, Chronic moderate to severe neurological disease, Significant heart disease treated with cardiac drugs, chronic liver & kidney disease, History of cardiovascular disease (myocardial infarction, congestive heart failure, angina, coronary artery disease or stroke) or cardiovascular disease requiring hospitalization, Known to be a carrier of the hepatitis B surface antigen, hepatitis C virus antibody, and/or immunodeficiency virus-1 and/ or 2 antibodies, Other disorder that may cause sexual dysfunction
5. Other sexual dysfunction: Erectile dysfunction, Primary reduced sexual desire unrelated to premature ejaculation
6. Sexual intercourse usually less than once per week;
7. Partner sexual dysfunction (for example vaginismus, hypoactive sexual desire, or other conditions considered relevant);
8. Current use of Dapoxetine;
9. Current use of any Tramadol;
10. Sensitivity to phenylketone;
11. Allergy to codeine or other opioids;
12. Has a known hypersensitivity to heparin or history of heparin induced thrombocytopenia;
13. Use of medication, within the preceding three months, with potential to cause sexual dysfunction: (See Appendix 2 of protocol for a list of excluded medications)
14. Recent psychotropic drug use (within the past three months);
15. Have drug or alcohol abuse or dependence within the past 6 months as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition;
16. Psychosexual counseling during the baseline or treatment periods;
17. Partner positive pregnancy test at pre-treatment screening and baseline;
18. History of clinically significant intolerance or a known hypersensitivity to Tramadol, such that treatment with it is contraindicated;
19. The Investigator anticipates that the subject will be unable to comply with the protocol;
20. Received any investigational drug within 30 days prior to the first dose of study medication or is scheduled to receive an investigational drug during the course of this study;
21. Has preplanned surgery or procedures that will occur during the course of the study.
22. A family member, other than the study partner, of an existing study subject, a staff member or relative.
23. Significant laboratory abnormality as determined by the investigator at baseline;
24. Significant ECG abnormality at baseline as determined by the investigator.
25. Any other illnesses or conditions that the investigator considers that should exclude the subject or that could interfere with the interpretation of the study results.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method