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

Bausch Health Americas, Inc.47 sites in 5 countries1,050 target enrollmentOctober 2009

ConditionsPremature Ejaculation

InterventionsTramadol Hydrochloride Placebo

DrugsTramadol Hydrochloride Placebo

Overview

Phase: Phase 3
Intervention: Tramadol Hydrochloride
Conditions: Premature Ejaculation
Sponsor: Bausch Health Americas, Inc.
Enrollment: 1050
Locations: 47
Primary Endpoint: Increase in IELT (Intravaginal ejaculatory time)
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2009

End Date

September 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Bausch Health Americas, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•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:

Exclusion Criteria

•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