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

Sponsor
Bausch Health Americas, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT00983736
Collaborator
(none)
1,050
Enrollment
48
Locations
2
Arms
11
Duration (Months)
21.9
Patients Per Site
2
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 patient and the patient's 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
  • Drug: 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 :
Oct 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
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: 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:
Yes
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

  1. 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 MHAT, Urology Clinic, 8A G. Kochev Str. Pleven Bulgaria
2 MHAT Plovdiv Plovdiv Bulgaria
3 MHAT Sveti Georgl Plovdiv, Urology Clinic, 66 Peshtersko Shosse Str. Plovdiv Bulgaria
4 MHAT Ruse, Urology Depart., 2 Nezavisimost Str. Rouse Bulgaria
5 CCB SAI Ministry of Interior, 79A, Skobelev Blvd. Sofia Bulgaria
6 MHAT Aleksandrovska, Urology Clinic, 1st, Georgi Sofiski Str. Sofia Bulgaria
7 MHAT Doverie, Urology Depart, 2 Ovcha Kupel, Quadrant 18 Sofia Bulgaria
8 SHAT Endocrinology "Academic Ivan Penchev" Sofia Bulgaria
9 MHAT DR Stefan Cherkezov Tarnovo Bulgaria
10 MHAT "Sveta Anna" Varna Urology Clinic Varna Bulgaria 9002
11 Urazova Nemocnice v Brne Brno Czech Republic
12 Andrologicka Ambulance Hradec Kralove Czech Republic
13 Psychiatricke Oddeienf and Sexuologicka Ambulance Pardubice Czech Republic
14 Soukroma Sexuologicka a Psychiatricka Ambulance Plzen Czech Republic
15 Androgeos S. R. O. Praha Czech Republic
16 Fakultni Thomayerova Nemocnice Praha Czech Republic
17 TH Klinika S.R.O. Praha Czech Republic
18 Urologicka Klinika S.R.O. Praha Czech Republic
19 Medicentrum Olomouc, S.T.O. Repcin Czech Republic
20 Allami Egeszegugyi Kozpont (State Health Center) Budapest Hungary
21 Donatella 99BT Private Healthcare Center Budapest Hungary
22 Erector Clinic Uro-Szexologiai Centrum Budapest Hungary
23 Semmelwiis Egyetem Urolgiai Klinika Budapest Hungary
24 Mediroyal Prevention Center Gyore Hungary
25 Soproni Erzesebet Oktato Korhaz Gyore Hungary
26 Szegeci Tudomanyegyetem Altalanos Orvostudomanyl Kar Urologial Kinika Kalvaria Hungary
27 Sandor Egeszegogyl Kozpont Vinar Hungary
28 Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok Poland
29 Klinika Urologii Uniwersytet Medyczny Gdansk Poland 80-402
30 Nzoz Vip-Med Gdynia Poland
31 Indywidualna Specjalistyczna Praktyka Lekarska Katowice Poland
32 Prywatna Praktyka Seksuologiczna Lodz Poland
33 Indywidualna Specjalistyczna Praktyka Lekarska Poznan Poland
34 Indywidualna Specjalistyczna Praktyka Lekarska Polozniczo-Ginekologiczno-Seksuologiczna Szczecin Poland
35 Nzoz 'Constans-Med' Todz Poland
36 Szaleckl Lempicki Spolka Partnersaka Lekarzy Urologow Warsaw Poland
37 MEDEA Specialistyczny Warszawa Poland
38 Poradnia Seksuologii i Patologll Wiezl Miedzyludzkich Warszawa Poland
39 Gabinet Lekanski Dr. Med. Ryszard Smolinski Wroclaw Poland
40 Spitalul Clinic de Urgenta "Sf. Loan", Urologie Bucuresti Romania
41 Spitalul Clinic de Urgenta Militar Central "Dr. Carol Davila" Bucuresti Romania
42 Spitalul Clinicl Prof. Theodor Burghele, Sectia Urologie II Bucuresti Romania
43 Uro-andro-Med SRL Bucuresti Romania
44 Provita 2000 SRL Constanta Romania
45 Spitalul Clinic Judetean de Urgenta Craiova, Sectia Urologie Craiova Romania
46 Spitalul Clinic Constantin Bucuras Judetul Timis Romania
47 Spitalul Clinic Judetean de Urgenta Oradea, Urologie Oradea Romania
48 Centrul Medical 'SF. Pantelimon', Cabinetul de Urologie Pantelimon Romania

Sponsors and Collaborators

  • Bausch Health Americas, Inc.

Investigators

  • Principal Investigator: Peter Nyiradi, MD, Mediroyal Prevention Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier:
NCT00983736
Other Study ID Numbers:
  • BVF-324-302
First Posted:
Sep 24, 2009
Last Update Posted:
Aug 27, 2012
Last Verified:
Nov 1, 2010
Additional relevant MeSH terms:
Premature Birth
Premature Ejaculation
Tramadol

Study Results

No Results Posted as of Aug 27, 2012