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

NCT ID: NCT00983736

Last Updated: 2012-08-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1050 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• 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 patient and the patient's 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

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

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

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

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: Yes

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Nyiradi, MD

Role: PRINCIPAL_INVESTIGATOR

Mediroyal Prevention Center

Locations

MHAT, Urology Clinic, 8A G. Kochev Str.

Pleven, , Bulgaria

MHAT Plovdiv

Plovdiv, , Bulgaria

MHAT Sveti Georgl Plovdiv, Urology Clinic, 66 Peshtersko Shosse Str.

Plovdiv, , Bulgaria

MHAT Ruse, Urology Depart., 2 Nezavisimost Str.

Rousse, , Bulgaria

CCB SAI Ministry of Interior, 79A, Skobelev Blvd.

Sofia, , Bulgaria

MHAT Aleksandrovska, Urology Clinic, 1st, Georgi Sofiski Str.

Sofia, , Bulgaria

MHAT Doverie, Urology Depart, 2 Ovcha Kupel, Quadrant 18

Sofia, , Bulgaria

SHAT Endocrinology "Academic Ivan Penchev"

Sofia, , Bulgaria

MHAT "Sveta Anna" Varna Urology Clinic

Varna, , Bulgaria

MHAT DR Stefan Cherkezov

Veliko Tarnovo, , Bulgaria

Urazova Nemocnice v Brne

Brno, , Czechia

Andrologicka Ambulance

Hradec Králové, , Czechia

Psychiatricke Oddeienf and Sexuologicka Ambulance

Pardubice, , Czechia

Soukroma Sexuologicka a Psychiatricka Ambulance

Pilsen, , Czechia

Androgeos S. R. O.

Prague, , Czechia

Fakultni Thomayerova Nemocnice

Prague, , Czechia

TH Klinika S.R.O.

Prague, , Czechia

Urologicka Klinika S.R.O.

Prague, , Czechia

Medicentrum Olomouc, S.T.O.

Řepčín, , Czechia

Allami Egeszegugyi Kozpont (State Health Center)

Budapest, , Hungary

Donatella 99BT Private Healthcare Center

Budapest, , Hungary

Erector Clinic Uro-Szexologiai Centrum

Budapest, , Hungary

Semmelwiis Egyetem Urolgiai Klinika

Budapest, , Hungary

Mediroyal Prevention Center

Györe, , Hungary

Soproni Erzesebet Oktato Korhaz

Györe, , Hungary

Szegeci Tudomanyegyetem Altalanos Orvostudomanyl Kar Urologial Kinika

Kálvária, , Hungary

Sandor Egeszegogyl Kozpont

Vinár, , Hungary

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, , Poland

Klinika Urologii Uniwersytet Medyczny

Gdansk, , Poland

Nzoz Vip-Med

Gdynia, , Poland

Indywidualna Specjalistyczna Praktyka Lekarska

Katowice, , Poland

Prywatna Praktyka Seksuologiczna

Lodz, , Poland

Indywidualna Specjalistyczna Praktyka Lekarska

Poznan, , Poland

Indywidualna Specjalistyczna Praktyka Lekarska Polozniczo-Ginekologiczno-Seksuologiczna

Szczecin, , Poland

Nzoz 'Constans-Med'

Todz, , Poland

MEDEA Specialistyczny

Warsaw, , Poland

Poradnia Seksuologii i Patologll Wiezl Miedzyludzkich

Warsaw, , Poland

Szaleckl Lempicki Spolka Partnersaka Lekarzy Urologow

Warsaw, , Poland

Gabinet Lekanski Dr. Med. Ryszard Smolinski

Wroclaw, , Poland

Spitalul Clinic de Urgenta "Sf. Loan", Urologie

Bucharest, , Romania

Spitalul Clinic de Urgenta Militar Central "Dr. Carol Davila"

Bucharest, , Romania

Spitalul Clinicl Prof. Theodor Burghele, Sectia Urologie II

Bucharest, , Romania

Uro-andro-Med SRL

Bucharest, , Romania

Provita 2000 SRL

Constanța, , Romania

Spitalul Clinic Judetean de Urgenta Craiova, Sectia Urologie

Craiova, , Romania

Spitalul Clinic Constantin Bucuras

Judetul Timis, , Romania

Spitalul Clinic Judetean de Urgenta Oradea, Urologie

Oradea, , Romania

Centrul Medical 'SF. Pantelimon', Cabinetul de Urologie

Pantelimon, , Romania

Countries

Bulgaria; Czechia; Hungary; Poland; Romania

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-324-302

Identifier Type: -

Identifier Source: org_study_id