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

Premature Ejaculation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00983736
• Other study ID #: BVF-324-302
• Status: Terminated
• Phase: Phase 3
• First received: September 22, 2009
• Last updated: August 24, 2012
• Start date: October 2009
• Est. completion date: September 2010

Study information

• Verified date: November 2010
• Source: Valeant Pharmaceuticals International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Ministry of HealthCzech Republic: Ethics CommitteeHungary: National Institute of PharmacyPoland: Ethics CommitteeRomania: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1050
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Bulgaria	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.	Rouse
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 DR Stefan Cherkezov	Tarnovo
Bulgaria	MHAT "Sveta Anna" Varna Urology Clinic	Varna
Czech Republic	Urazova Nemocnice v Brne	Brno
Czech Republic	Andrologicka Ambulance	Hradec Kralove
Czech Republic	Psychiatricke Oddeienf and Sexuologicka Ambulance	Pardubice
Czech Republic	Soukroma Sexuologicka a Psychiatricka Ambulance	Plzen
Czech Republic	Androgeos S. R. O.	Praha
Czech Republic	Fakultni Thomayerova Nemocnice	Praha
Czech Republic	TH Klinika S.R.O.	Praha
Czech Republic	Urologicka Klinika S.R.O.	Praha
Czech Republic	Medicentrum Olomouc, S.T.O.	Repcin
Hungary	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	Gyore
Hungary	Soproni Erzesebet Oktato Korhaz	Gyore
Hungary	Szegeci Tudomanyegyetem Altalanos Orvostudomanyl Kar Urologial Kinika	Kalvaria
Hungary	Sandor Egeszegogyl Kozpont	Vinar
Poland	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	Szaleckl Lempicki Spolka Partnersaka Lekarzy Urologow	Warsaw
Poland	MEDEA Specialistyczny	Warszawa
Poland	Poradnia Seksuologii i Patologll Wiezl Miedzyludzkich	Warszawa
Poland	Gabinet Lekanski Dr. Med. Ryszard Smolinski	Wroclaw
Romania	Spitalul Clinic de Urgenta "Sf. Loan", Urologie	Bucuresti
Romania	Spitalul Clinic de Urgenta Militar Central "Dr. Carol Davila"	Bucuresti
Romania	Spitalul Clinicl Prof. Theodor Burghele, Sectia Urologie II	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	Spitalul Clinic Judetean de Urgenta Oradea, Urologie	Oradea
Romania	Centrul Medical 'SF. Pantelimon', Cabinetul de Urologie	Pantelimon

Sponsors (1)

Lead Sponsor	Collaborator
Valeant Pharmaceuticals International, Inc.

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Hungary,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in IELT (Intravaginal ejaculatory time)		Per attempt at sexual intercourse	No
Secondary	Efficacy of using Tramadol for Premature Ejaculation		At each attempt	No