A Phase 2 multi-center, open label, long-term extension trial to assess the safety of oral UK-390,957 administered as required in adult men with premature ejaculation - N/A

• Conditions: Premature Ejaculation; MedDRA version: 7.1Level: LLTClassification code 10036596

• Registration Number: EUCTR2004-003737-13-GB
• Lead Sponsor: Pfizer Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-18
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 1058

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
1. Subject is a male =18 years of age
2. Subject has provided written informed consent
3. Subject continues to have a monogamous, stable heterosexual relationship

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects presenting with any of the following will not be included in the trial:
1. Subject develops other forms of sexual dysfunction (erectile, retrograde, anejaculation, painful ejaculation, hypoactive sexual desire disorder, inhibited or absent orgasms)
2. Subject who requires any form of treatment for depression including counseling or psychotherapy or with a past medical history of mania, hypomania or bipolar disorder
3. Since completing the previous trial the subject has begun taking SSRIs or tricyclic antidepressants or drugs with significant interactions with SSRIs such as: anticoagulants, anti migraine agents, theophylline, tryptophan, St. John’s Wort, lithium, dextromethorphan, reversible or irreversible Monoamine Oxidase inhibitors (RIMAs or MAOIs)
4. Subject has developed a condition for which SSRIs are contraindicated, such as:
a. History of narrow angle glaucoma
b. History of seizures
c. History of bleeding disorders
d. At risk for volume depletion
e. Clinically significant (severe) hepatic or renal impairment
5. Subject has developed severe allergies or hypersensitivity or multiple adverse drug reactions to the class of SSRIs
6. Subject intends to donate blood or blood products during the period of the trial or within 1 month of the trial’s completion.
7. Subject has developed any medical or psychological condition or social circumstances that would impair his ability to participate reliably in the trial or who may increase risk to himself or others by participating.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety and tolerability of oral UK-390,957 administered to adult men with premature ejaculation who have successfully completed 1 of the Pfizer trials A3871022, A3871027 or A3871029. ;Secondary Objective: ;Primary end point(s): Safety<br>1. Will be determined by laboratory testing (only clinically significant laboratory abnormalities will be summarized).<br>2. Adverse events will be monitored. Serious adverse events, discontinuations due to adverse events during the study and following withdrawal will be summarized.<br>3. Adverse events will be considered with respect to frequency of drug use.