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 Ejaculation
MedDRA version: 9.1Level: LLTClassification code 10036596Term: Premature ejaculation

Registration Number: EUCTR2009-011411-21-HU

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

Inclusion Criteria

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

Exclusion Criteria

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
Main Objective: The co-primary objectives of the study are to evaluate the efficacy of two different doses of Tramadol in delaying<br>the Intravaginal Ejaculation Latency Time (IELT) and improving the Premature Ejaculation Profile (PEP).;Secondary Objective: The secondary objective is to evaluate the safety of the same two doses of Tramadol when given to delay<br>ejaculation.;Primary end point(s): The following information will be collected as primary endpoints to evaluate the efficacy of Tramadol HCl ODT:<br>• IELT<br>• PEP – a composite endpoint male and female questionnaire<br>The secondary efficacy measures will consist of the following assessments:<br>• International Index of Erectile Function (IIEF-5)<br>• Sexual Quality of Life for Men Questionnaire (SQOL-M)<br>• Subject Global Satisfaction Assessment

Secondary Outcome Measures

Name	Time	Method

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