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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00983151
Other study ID # BVF-324-301
Secondary ID
Status Terminated
Phase Phase 3
First received September 22, 2009
Last updated August 24, 2012
Start date August 2009
Est. completion date September 2010

Study information

Verified date October 2010
Source Valeant Pharmaceuticals International, Inc.
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Office for Safety in Health CareBelgium: Federal Agency for Medicinal Products and Health ProductsFrance: Ministry of HealthGermany: Ministry of HealthItaly: Ethics CommitteeNetherlands: Independent Ethics CommitteeSpain: Ethics CommitteeSweden: Regional Ethical Review BoardUnited Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this clinical trial is to test an experimental drug therapy called Tramadol Hydrochloride (HCl) Orally Disintegrating Tablets (ODT) ("Tramadol HCl ODT" or the "study drug"). The subject and his partner are being asked to be in this clinical trial because they have a condition called premature ejaculation.


Recruitment information / eligibility

Status Terminated
Enrollment 1050
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

Subjects are eligible for study participation if all of the following criteria are met:

1. Male subject and female 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 ("lifelong" is defined as starting at the time the subject became sexually active) with an IELT of =120 seconds as documented at Visit 2.

3. History of premature or rapid ejaculation, determined by following criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV TR):

1. 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

2. The disturbance causes marked distress or interpersonal difficulty

3. 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 engage in vaginal intercourse at least three times between visits to yield at least three events of vaginal intercourse ;

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 tests at Visits 1 and 2

12. Subject willing to list and document prescription and non-prescription drug use during the study;

13. Have a negative urine drug screen at Visits 1 and 2;

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. Premature ejaculation attributable to situational or relationship issues;

2. Evidence or a history of other significant psychiatric disorder as defined as 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 ii.Prostatitis (current) iii.Urethritis or other urinary tract infections (current) iv.Prior genital surgery (other than vasectomy or circumcision) v.Uncontrolled Diabetes mellitus vi.Respiratory Depression vii.Thyroid disease viii.Chronic moderate to severe neurological disease ix.Significant heart disease treated with cardiac drugs x.Chronic liver disease xi.Chronic kidney disease xii.History of cardiovascular disease (myocardial infarction, congestive heart failure, angina, coronary artery disease or stroke) xiii.Known to be a carrier of the hepatitis B surface antigen, hepatitis C virus antibody, and/or immunodeficiency virus-1 and/ or 2 antibodies xiv.Other disorder that may cause sexual dysfunction

5. 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

6. Sexual intercourse usually less than once per week;

7. Partner sexual dysfunction (for example dyspareunia or other conditions considered relevant);

8. Current use of dapoxetine;

9. Current use of any tramadol;

10. Sensitivity to phenylketone;

11. Any history of abuse of prescription opioids and/or illicit/illegal addictive drugs;

12. Has a known hypersensitivity to heparin or history of heparin induced thrombocytopenia;

13. 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

14. Recent psychotropic drug use (within the past 30 days);

15. A history of alcohol abuse or dependence within the past 6 months as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV TR);

16. Initiation of psychosexual counseling during the screening, baseline or treatment periods;

17. Partner positive pregnancy test at Visit 1 or 2;

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 Visit 1 or is scheduled to receive an investigational drug during the course of this study;

21. Has preplanned surgery or procedures that would interfere with the course of the study.

22. A family member (other than the female partner), a staff member, or relative of a staff member..

23. Significant laboratory abnormality as determined by the Investigator at Visit 1;

24. Significant ECG abnormality at Visit 1 as determined by the Investigator;

25. Any other illnesses, conditions or practices that in the Investigator's opinion could interfere with the collection and/or interpretation of study results (couples using the "Withdrawal Method" of birth control will be excluded from the study).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Austria Innsbruck Medical university Innsbruck
Belgium Ziekenhuisnelwerk Antwerpen (ZNA), Campus Stuvenberg-St. Erasmus Antwerpen
Belgium UZ Brussel, Laarbeeklaan 101 Brussel
Belgium Clinique St. Jean, Depart. of Urology, Blvd du Jardin Botanique, 32 Bruxelles
Belgium Universitair Ziekenhuls Antwerpen (UZA), Wirjkstraat 10 Edegem
Belgium Universitair Ziekenhuis Gent Gent
Belgium CHU Sart Tilman Liege
France CHU de Nimes-Groupe Hospitalo-Universitaire, Pharmacie Secteur Essals Cliniques, Cedex
France Hopital Raymond Poincar'e, 104 Bvld. Raymond Poincar'e Garches
France Hopital Henry Gabrielle Laval
France Porle Bouqueyre Le Parc Saint Maur
France CETPARPjj Lille
France hopital Edouard Herriot Lyon
France Institut de Medecine Sexuelle Marseille
France Hopital Pasteur Nice
France 11 rue Magellan Paris
France Cabinet medical Paris
France 76 rue d'Antain, 35700 Rennes Rennes
France Cabinet medical, 10 rue de la Trinite Toulouse
Germany Dederweg 2-4 Frankfurt
Germany University Hospital Halle Halle
Germany Institut fur Mannergesundheit Universitakslinikum Hamburg-Eppendorf Hamburg
Germany Medizinische Hochschule Hannover Zentrum for Seelische Gesundhelt Hannover
Germany Abetellung for Andrologie & Urologie PAN-Kilnik am Neumarkt Koin
Germany PUR/R Praxisklinik Urologie 3 Rhein Ruhr Muhlheim
Netherlands Academic Medical Center, Depart. of Urology Amsterdam
Netherlands Geert Grooteplein Zuid Nijmegen
Spain Hospital Universitario Reina Sofla Cordoba
Spain Hospital Universitario Fundacion Alcordon Madrid
Spain Clinica El Angel Malaga
Spain Hospital Universitario Virgen de Rocio Sevilla
Sweden DW Medical Eskilstuna
Sweden Carlanderska Sjukhuset Goteborg
Sweden Urohalsan Jonkoping
Sweden ProbarE AB Lund
Sweden ProbarE AB Solna
Sweden Karolinska University hospital-Huddinge Stockholm
Sweden S3 Clinical Research Centers Vällingby

Sponsors (1)

Lead Sponsor Collaborator
Valeant Pharmaceuticals International, Inc.

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Netherlands,  Spain,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Increase in IELT (Intravaginal ejaculatory time) Per attempt at sexual intercourse No
Secondary Efficacy of using Tramadol for Premature Ejaculation. At each attempt No
See also
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Completed NCT02794454 - A Study to Evaluate Efficacy of Investigational Product HeezOn Ultra -1/ HeezOn Ultra-2 on Male Sexual Health N/A
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