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

2014-07-24 14:11:26 | BioPortfolio

Summary

The purpose of this clinical trial is to test an experimental drug therapy, which contains a medication 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.

Study Design

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

Conditions

Premature Ejaculation

Intervention

Tramadol Hydrochloride, Placebo

Location

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

Status

Recruiting

Source

Biovail Laboratories International SRL

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:11:26-0400

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

The purpose of this clinical trial is to test an experimental drug therapy, which contains a medication called Tramadol Hydrochloride (HCl) Orally Disintegrating Tablets (ODT) ("Tramadol H...

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The purpose of this study is to determine the effectiveness of IX-01 in men with lifelong premature ejaculation.

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PubMed Articles [1784 Associated PubMed Articles listed on BioPortfolio]

Tramadol Hydrochloride at Steady State Lacks Clinically Relevant QTc Interval Increases in Healthy Adults.

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The aim of the present trial is to assess the efficacy of on-demand clomipramine 15 mg administered before sexual intercourse for the treatment of premature ejaculation (PE).

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Medical and Biotech [MESH] Definitions

The emission of SEMEN and seminal fluid during the act of preparation for sexual intercourse, i.e. before there is penetration, or shortly after penetration.

A type of cardiac arrhythmia with premature contractions of the HEART VENTRICLES. It is characterized by the premature QRS complex on ECG that is of abnormal shape and great duration (generally >129 msec). It is the most common form of all cardiac arrhythmias. Premature ventricular complexes have no clinical significance except in concurrence with heart diseases.

Onset of OBSTETRIC LABOR before term (TERM BIRTH) but usually after the FETUS has become viable. In humans, it occurs sometime during the 29th through 38th week of PREGNANCY. TOCOLYSIS inhibits premature labor and can prevent the BIRTH of premature infants (INFANT, PREMATURE).

The premature cessation of menses (MENSTRUATION) when the last menstrual period occurs in a woman under the age of 40. It is due to the depletion of OVARIAN FOLLICLES. Premature MENOPAUSE can be caused by diseases; OVARIECTOMY; RADIATION; chemicals; and chromosomal abnormalities.

A type of cardiac arrhythmia with premature atrial contractions or beats caused by signals originating from ectopic atrial sites. The ectopic signals may or may not conduct to the HEART VENTRICLES. Atrial premature complexes are characterized by premature P waves on ECG which are different in configuration from the P waves generated by the normal pacemaker complex in the SINOATRIAL NODE.

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