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

Phase 3

Terminated

• Conditions: Premature Ejaculation
• Interventions: Drug: Placebo; Drug: Tramadol Hydrochloride

• Registration Number: NCT00983736
• Lead Sponsor: Bausch Health Americas, Inc.

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 patient and the patient's partner are being asked to be in this clinical trial because they have a condition called Premature Ejaculation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-23
• Study First Posted: 2009-09-24
• Study Start: 2009-10
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2010-11
• Last Update Submitted: 2012-08-24
• Last Update Posted: 2012-08-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 1050

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Active	Tramadol Hydrochloride	-

Primary Outcome Measures

Name	Time	Method
Increase in IELT (Intravaginal ejaculatory time)	Per attempt at sexual intercourse

Secondary Outcome Measures

Name	Time	Method
Efficacy of using Tramadol for Premature Ejaculation	At each attempt

Trial Locations

Locations (47)

MHAT Plovdiv; 🇧🇬 Plovdiv, Bulgaria

Spitalul Clinic de Urgenta Militar Central "Dr. Carol Davila"; 🇷🇴 Bucuresti, Romania

Psychiatricke Oddeienf and Sexuologicka Ambulance; 🇨🇿 Pardubice, Czech Republic

Fakultni Thomayerova Nemocnice; 🇨🇿 Praha, Czech Republic

Nzoz Vip-Med; 🇵🇱 Gdynia, Poland

Donatella 99BT Private Healthcare Center; 🇭🇺 Budapest, Hungary

MHAT "Sveta Anna" Varna Urology Clinic; 🇧🇬 Varna, Bulgaria

Soukroma Sexuologicka a Psychiatricka Ambulance; 🇨🇿 Plzen, Czech Republic

Androgeos S. R. O.; 🇨🇿 Praha, Czech Republic

Klinika Urologii Uniwersytet Medyczny; 🇵🇱 Gdansk, Poland

Indywidualna Specjalistyczna Praktyka Lekarska; 🇵🇱 Poznan, Poland

Prywatna Praktyka Seksuologiczna; 🇵🇱 Lodz, Poland

Nzoz 'Constans-Med'; 🇵🇱 Todz, Poland

Szaleckl Lempicki Spolka Partnersaka Lekarzy Urologow; 🇵🇱 Warsaw, Poland

MEDEA Specialistyczny; 🇵🇱 Warszawa, Poland

Gabinet Lekanski Dr. Med. Ryszard Smolinski; 🇵🇱 Wroclaw, Poland

Poradnia Seksuologii i Patologll Wiezl Miedzyludzkich; 🇵🇱 Warszawa, Poland

Spitalul Clinic de Urgenta "Sf. Loan", Urologie; 🇷🇴 Bucuresti, Romania

Uro-andro-Med SRL; 🇷🇴 Bucuresti, Romania

Provita 2000 SRL; 🇷🇴 Constanta, Romania

Spitalul Clinic Judetean de Urgenta Craiova, Sectia Urologie; 🇷🇴 Craiova, Romania

Spitalul Clinic Constantin Bucuras; 🇷🇴 Judetul Timis, Romania

Centrul Medical 'SF. Pantelimon', Cabinetul de Urologie; 🇷🇴 Pantelimon, Romania

MHAT Ruse, Urology Depart., 2 Nezavisimost Str.; 🇧🇬 Rouse, Bulgaria

MHAT Aleksandrovska, Urology Clinic, 1st, Georgi Sofiski Str.; 🇧🇬 Sofia, Bulgaria

MHAT DR Stefan Cherkezov; 🇧🇬 Tarnovo, Bulgaria

TH Klinika S.R.O.; 🇨🇿 Praha, Czech Republic

Mediroyal Prevention Center; 🇭🇺 Gyore, Hungary

Uniwersytecki Szpital Kliniczny w Bialymstoku; 🇵🇱 Bialystok, Poland

MHAT Sveti Georgl Plovdiv, Urology Clinic, 66 Peshtersko Shosse Str.; 🇧🇬 Plovdiv, Bulgaria

SHAT Endocrinology "Academic Ivan Penchev"; 🇧🇬 Sofia, Bulgaria

Andrologicka Ambulance; 🇨🇿 Hradec Kralove, Czech Republic

Medicentrum Olomouc, S.T.O.; 🇨🇿 Repcin, Czech Republic

Sandor Egeszegogyl Kozpont; 🇭🇺 Vinar, Hungary

Spitalul Clinic Judetean de Urgenta Oradea, Urologie; 🇷🇴 Oradea, Romania

Allami Egeszegugyi Kozpont (State Health Center); 🇭🇺 Budapest, Hungary

Urazova Nemocnice v Brne; 🇨🇿 Brno, Czech Republic

Spitalul Clinicl Prof. Theodor Burghele, Sectia Urologie II; 🇷🇴 Bucuresti, Romania

Erector Clinic Uro-Szexologiai Centrum; 🇭🇺 Budapest, Hungary

MHAT, Urology Clinic, 8A G. Kochev Str.; 🇧🇬 Pleven, Bulgaria

CCB SAI Ministry of Interior, 79A, Skobelev Blvd.; 🇧🇬 Sofia, Bulgaria

MHAT Doverie, Urology Depart, 2 Ovcha Kupel, Quadrant 18; 🇧🇬 Sofia, Bulgaria

Urologicka Klinika S.R.O.; 🇨🇿 Praha, Czech Republic

Soproni Erzesebet Oktato Korhaz; 🇭🇺 Gyore, Hungary

Szegeci Tudomanyegyetem Altalanos Orvostudomanyl Kar Urologial Kinika; 🇭🇺 Kalvaria, Hungary

Semmelwiis Egyetem Urolgiai Klinika; 🇭🇺 Budapest, Hungary

Indywidualna Specjalistyczna Praktyka Lekarska Polozniczo-Ginekologiczno-Seksuologiczna; 🇵🇱 Szczecin, Poland