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

Sponsor
Bausch Health Americas, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00983151
Collaborator
(none)
1,050
Enrollment
38
Locations
2
Arms
13
Duration (Months)
27.6
Patients Per Site
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tramadol Hydrochloride & Placebo
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1050 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Official Title:
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
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active

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
Placebo Comparator: Placebo

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

Outcome Measures

Primary Outcome Measures

  1. Increase in IELT (Intravaginal ejaculatory time) [Per attempt at sexual intercourse]

Secondary Outcome Measures

  1. Efficacy of using Tramadol for Premature Ejaculation. [At each attempt]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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:

  1. Female sexual partner willing and able to complete the therapeutic trial, all sexual behavior logs, IELT assessments, questionnaires and interviews;

  2. Able to understand the study procedures, complete the assessments, and communicate with study personnel;

  3. 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 ;

  4. Subject and partner willing to use a reliable contraceptive method during the trial period if the partner is not menopausal;

  5. Partner willing to take pregnancy tests at Visits 1 and 2

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

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

  8. 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

  1. Sexual intercourse usually less than once per week;

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

  3. Current use of dapoxetine;

  4. Current use of any tramadol;

  5. Sensitivity to phenylketone;

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

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

  8. 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

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

  2. 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);

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

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

  5. History of clinically significant intolerance or a known hypersensitivity to tramadol, such that treatment with it is contraindicated;

  6. The Investigator anticipates that the subject will be unable to comply with the protocol;

  7. 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;

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

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

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

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

  12. 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Innsbruck Medical university Innsbruck Austria
2 Ziekenhuisnelwerk Antwerpen (ZNA), Campus Stuvenberg-St. Erasmus Antwerpen Belgium
3 UZ Brussel, Laarbeeklaan 101 Brussel Belgium
4 Clinique St. Jean, Depart. of Urology, Blvd du Jardin Botanique, 32 Bruxelles Belgium
5 Universitair Ziekenhuls Antwerpen (UZA), Wirjkstraat 10 Edegem Belgium
6 Universitair Ziekenhuis Gent Gent Belgium
7 CHU Sart Tilman Liege Belgium
8 CHU de Nimes-Groupe Hospitalo-Universitaire, Pharmacie Secteur Essals Cliniques, Cedex France
9 Hopital Raymond Poincar'e, 104 Bvld. Raymond Poincar'e Garches France
10 Hopital Henry Gabrielle Laval France
11 Porle Bouqueyre Le Parc Saint Maur France
12 CETPARPjj Lille France
13 hopital Edouard Herriot Lyon France
14 Institut de Medecine Sexuelle Marseille France
15 Hopital Pasteur Nice France
16 11 rue Magellan Paris France
17 Cabinet medical Paris France
18 76 rue d'Antain, 35700 Rennes Rennes France
19 Cabinet medical, 10 rue de la Trinite Toulouse France
20 Dederweg 2-4 Frankfurt Germany
21 University Hospital Halle Halle Germany
22 Institut fur Mannergesundheit Universitakslinikum Hamburg-Eppendorf Hamburg Germany
23 Medizinische Hochschule Hannover Zentrum for Seelische Gesundhelt Hannover Germany
24 Abetellung for Andrologie & Urologie PAN-Kilnik am Neumarkt Koin Germany
25 PUR/R Praxisklinik Urologie 3 Rhein Ruhr Muhlheim Germany
26 Academic Medical Center, Depart. of Urology Amsterdam Netherlands
27 Geert Grooteplein Zuid Nijmegen Netherlands
28 Hospital Universitario Reina Sofla Cordoba Spain
29 Hospital Universitario Fundacion Alcordon Madrid Spain
30 Clinica El Angel Malaga Spain
31 Hospital Universitario Virgen de Rocio Sevilla Spain
32 DW Medical Eskilstuna Sweden
33 Carlanderska Sjukhuset Goteborg Sweden
34 Urohalsan Jonkoping Sweden
35 ProbarE AB Lund Sweden
36 ProbarE AB Solna Sweden 141 45
37 Karolinska University hospital-Huddinge Stockholm Sweden
38 S3 Clinical Research Centers Vällingby Sweden 162 68

Sponsors and Collaborators

  • Bausch Health Americas, Inc.

Investigators

  • Principal Investigator: Hubert Claes, MD, Clinique St Jean

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier:
NCT00983151
Other Study ID Numbers:
  • BVF-324-301
First Posted:
Sep 23, 2009
Last Update Posted:
Aug 27, 2012
Last Verified:
Oct 1, 2010
Additional relevant MeSH terms:
Premature Birth
Premature Ejaculation
Tramadol

Study Results

No Results Posted as of Aug 27, 2012