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

NCT00983736 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1050

Last updated 2012-08-27

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Principal Investigators

  • Peter Nyiradi, MD · Mediroyal Prevention Center

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Bulgaria
  • Czechia
  • Hungary
  • Poland
  • Romania

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00983736 on ClinicalTrials.gov