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

• Conditions: Premature Ejaculation; MedDRA version: 7.0Level: LLTClassification code 10036596

• Registration Number: EUCTR2004-003737-13-SE
• Lead Sponsor: Pfizer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11-10
• Last Update Posted: 1 May 2012

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 thetrial:
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.
4. Subject and his partner are willing to use a timer for attempts at sexual intercourse for 14 days prior to visits at 12, 24 and 52 weeks.
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 glaucomab. History of seizuresc. History of bleeding disordersd. At risk for volume depletione. Clinically significant (severe) hepatic or renal impairment.
5. Subject has developed severe allergies or hypersensitivity or multiple adverse drug reactionsto 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