Study to Evaluate Efficacy and Safety in Males Subjects With Premature Ejaculation

NCT ID: NCT00983151

Last Updated: 2012-08-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1050 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-09-30

Brief 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.

Conditions

Premature Ejaculation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Active

Group Type: EXPERIMENTAL

Tramadol Hydrochloride & Placebo

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Tramadol Hydrochloride & Placebo

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hubert Claes, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique St Jean

Locations

Innsbruck Medical university

Innsbruck, , Austria

Ziekenhuisnelwerk Antwerpen (ZNA), Campus Stuvenberg-St. Erasmus

Antwerp, , Belgium

Clinique St. Jean, Depart. of Urology, Blvd du Jardin Botanique, 32

Brussels, , Belgium

UZ Brussel, Laarbeeklaan 101

Brussels, , Belgium

Universitair Ziekenhuls Antwerpen (UZA), Wirjkstraat 10

Edegem, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

CHU Sart Tilman

Liège, , Belgium

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

CETPARPjj

Lille, , France

hopital Edouard Herriot

Lyon, , France

Institut de Medecine Sexuelle

Marseille, , France

Hopital Pasteur

Nice, , France

Porle Bouqueyre

Parc Saint-Maur, , 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, , France

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

Hanover, , Germany

Abetellung for Andrologie & Urologie PAN-Kilnik am Neumarkt

Koin, , Germany

PUR/R Praxisklinik Urologie 3 Rhein Ruhr

Mühlheim, , Germany

Academic Medical Center, Depart. of Urology

Amsterdam, , Netherlands

Geert Grooteplein Zuid

Nijmegen, , Netherlands

Hospital Universitario Reina Sofla

Córdoba, , Spain

Hospital Universitario Fundacion Alcordon

Madrid, , Spain

Clinica El Angel

Málaga, , Spain

Hospital Universitario Virgen de Rocio

Seville, , Spain

DW Medical

Eskilstuna, , Sweden

Carlanderska Sjukhuset

Gothenburg, , Sweden

Urohalsan

Jönköping, , Sweden

ProbarE AB

Lund, , Sweden

ProbarE AB

Solna, , Sweden

Karolinska University hospital-Huddinge

Stockholm, , Sweden

S3 Clinical Research Centers

Vällingby, , Sweden

Countries

Austria; Belgium; France; Germany; Netherlands; Spain; Sweden

References

Bar-Or D, Salottolo KM, Orlando A, Winkler JV; Tramadol ODT Study Group. A randomized double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of two doses of the tramadol orally disintegrating tablet for the treatment of premature ejaculation within less than 2 minutes. Eur Urol. 2012 Apr;61(4):736-43. doi: 10.1016/j.eururo.2011.08.039. Epub 2011 Aug 30.

Reference Type: DERIVED

PMID: 21889833 (View on PubMed)

Other Identifiers

BVF-324-301

Identifier Type: -

Identifier Source: org_study_id