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

NCT00983151 | Terminated Phase 3

• 1 other identifier: BVF-324-301
• Study Type: interventional
• Target: 1,050
• Locations: 7 countries
• Sites: 38

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

Outcome Measures

Primary Outcomes (1)

• Increase in IELT (Intravaginal ejaculatory time)

  Per attempt at sexual intercourse

Secondary Outcomes (1)

• Efficacy of using Tramadol for Premature Ejaculation.

  At each attempt

Study Arms (2)

Active

EXPERIMENTAL

Drug: Tramadol Hydrochloride & Placebo

Placebo

PLACEBO COMPARATOR

Drug: Tramadol Hydrochloride & Placebo

Interventions

Tramadol Hydrochloride & Placebo 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

Active; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are eligible for study participation if all of the following criteria are met:
• Male subject and female partner to provide written informed consent prior to the performance of any study-specific procedures;
• 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.
• History of premature or rapid ejaculation, determined by following criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV TR):
• 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
• In a stable, monogamous, heterosexual relationship (\> 6 months).
• Willing and able to take study medication as directed at least 2 hours prior to sexual intercourse according to protocol;
• Subject willing and able to complete the therapeutic trial, all sexual behavior logs, IELT assessments, questionnaires and interviews:
• Female sexual partner willing and able to complete the therapeutic trial, all sexual behavior logs, IELT assessments, questionnaires and interviews;
• Able to understand the study procedures, complete the assessments, and communicate with study personnel;
• 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 ;
• Subject and partner willing to use a reliable contraceptive method during the trial period if the partner is not menopausal;
• Partner willing to take pregnancy tests at Visits 1 and 2

You may not qualify if:

• Subjects are not eligible for study participation if any of the following criteria are met:
• Premature ejaculation attributable to situational or relationship issues;
• Evidence or a history of other significant psychiatric disorder as defined as requiring therapy or medication;
• Subjects who in the Investigator's opinion are at significant risk of suicide.
• 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
• 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
• Sexual intercourse usually less than once per week;
• Partner sexual dysfunction (for example dyspareunia or other conditions considered relevant);
• Current use of dapoxetine;
• Current use of any tramadol;
• Sensitivity to phenylketone;
• Any history of abuse of prescription opioids and/or illicit/illegal addictive drugs;

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (38)

Innsbruck Medical university

Innsbruck, Austria

Location

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

Antwerp, Belgium

Location

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

Brussels, Belgium

Location

UZ Brussel, Laarbeeklaan 101

Brussels, Belgium

Location

Universitair Ziekenhuls Antwerpen (UZA), Wirjkstraat 10

Edegem, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

CHU Sart Tilman

Liège, Belgium

Location

CHU de Nimes-Groupe Hospitalo-Universitaire, Pharmacie Secteur Essals Cliniques,

Cedex, France

Location

Hopital Raymond Poincar'e, 104 Bvld. Raymond Poincar'e

Garches, France

Location

Hopital Henry Gabrielle

Laval, France

Location

CETPARPjj

Lille, France

Location

hopital Edouard Herriot

Lyon, France

Location

Institut de Medecine Sexuelle

Marseille, France

Location

Hopital Pasteur

Nice, France

Location

Porle Bouqueyre

Parc Saint-Maur, France

Location

11 rue Magellan

Paris, France

Location

Cabinet medical

Paris, France

Location

76 rue d'Antain, 35700 Rennes

Rennes, France

Location

Cabinet medical, 10 rue de la Trinite

Toulouse, France

Location

Dederweg 2-4

Frankfurt, Germany

Location

University Hospital Halle

Halle, Germany

Location

Institut fur Mannergesundheit Universitakslinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Medizinische Hochschule Hannover Zentrum for Seelische Gesundhelt

Hanover, Germany

Location

Abetellung for Andrologie & Urologie PAN-Kilnik am Neumarkt

Koin, Germany

Location

PUR/R Praxisklinik Urologie 3 Rhein Ruhr

Mühlheim, Germany

Location

Academic Medical Center, Depart. of Urology

Amsterdam, Netherlands

Location

Geert Grooteplein Zuid

Nijmegen, Netherlands

Location

Hospital Universitario Reina Sofla

Córdoba, Spain

Location

Hospital Universitario Fundacion Alcordon

Madrid, Spain

Location

Clinica El Angel

Málaga, Spain

Location

Hospital Universitario Virgen de Rocio

Seville, Spain

Location

DW Medical

Eskilstuna, Sweden

Location

Carlanderska Sjukhuset

Gothenburg, Sweden

Location

Urohalsan

Jönköping, Sweden

Location

ProbarE AB

Lund, Sweden

Location

ProbarE AB

Solna, 141 45, Sweden

Location

Karolinska University hospital-Huddinge

Stockholm, Sweden

Location

S3 Clinical Research Centers

Vällingby, 162 68, Sweden

Location

Related Publications (1)

• 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.

  PMID: 21889833 DERIVED

MeSH Terms

Conditions

Premature Ejaculation

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Hubert Claes, MD

  Clinique St Jean

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 23, 2009
• Study Start: August 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: August 27, 2012

Record last verified: 2010-10

Locations

NL (2); AU (1); FR (12); DE (6); ES (4); SE (7); BE (6)