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.
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):
- 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
- The disturbance causes marked distress or interpersonal difficulty
- 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.
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
- 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 disease
- Chronic 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 phenylacetone;
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 for a list of excluded medications)
- Antidepressants - all types
- Antipsychotic medication
- Antihypertensive medication, unless on a stable dose > 6 months
- Hormonal drugs
- Chemotherapy
- Others: cimetidine, clofibrate,quinidine
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.
