A Phase 2b, multi-center, double-blind, placebo-controlled, parallel group dose response study to assess the efficacy and safety of oral UK-390,957 in men with premature ejaculation. - N/A

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

Registration Number: EUCTR2004-000244-24-SE

Lead Sponsor: Pfizer AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 460

Inclusion Criteria

1) Subject is an adult male = 18 years of age
2) Subject has provided written informed consent before screening
3) Subject meets the diagnostic criteria for PE as specified in DSM-IV-TR™ for at least the last 6 months (Appendix E)
4) Subject has a stable, monogamous, heterosexual relationship & sexually active for at least the last 6 months
5) Subject and his female partner are willing to engage in at least 4 attempts at sexual intercourse between clinic Visits (Screening to Baseline, Baseline to Visit 3, Visit 3 to Visit 4 and Visit 4 to Visit 5)
6) Subject has recorded in the electronic diary at least 4 intravaginal penetrations, during the run-in period i.e. between the screening visit (Visit 1) and the baseline visit (Visit 2), of which at least 70% show an intravaginal ejaculatory latency time (IELT) of less than or equal to 2 minutes. The 70% of occasions will be calculated as the 70th percentile of the IELTs in the run-in period
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Subject has never achieved an intravaginal ejaculation during the past 6 months (i.e. always ejaculates prior to penetration)
2) Subject has other forms of ejaculatory dysfunction (e.g. retrograde ejaculation, anejaculation, painful ejaculation)
3) Subject has a urinary tract infection. Subjects with a positive leukocyte esterase or nitrate test on dipstick testing, must have a urinary tract infection (UTI) ruled out prior to randomization. Subjects found to have a UTI must be treated before being rescreened
4) Subject has a history of erectile dysfunction (ED), or is currently receiving treatment for ED or has a score of <22 on the Erectile Function Domain Score (Appendix L)
5) Subject has other sexual disorders such as hypoactive sexual desire disorder and inhibited or absent orgasm
6) Subject has any other condition, psychiatric, medical (e.g. prostatitis or urethritis) or surgical (e.g. non-retractable foreskin), that in the investigator’s judgment may impact the subject’s ejaculatory function
7) Subject is unwilling to stop for the duration of the study any method of delaying ejaculation, such as: a) Use of multiple condoms or those condoms specifically marketed for the purpose of decreasing penile sensitivity. (The use of single condoms for contraceptive purposes is permitted) b) Engaging in masturbation (stimulation) to ejaculation in the period prior to sexual intercourse c) Pause-squeeze technique or other forms of behavioral therapy d) Counseling or psychotherapy (specifically for this purpose) e) Use of alcohol or any other substance (specifically for this purpose) f) Any penile rings/desensitizing bands
8) In the 2 weeks prior to the screening visit, subject has used any treatment including devices, oral agents (e.g. SSRIs, tricyclic antidepressants, major tranquilizers, anxiolytics, alpha blockers, PDE-5 inhibitors, herbal treatments or other over-the-counter remedies), topical agents (e.g. anesthetic creams/sprays), or injection therapies for PE
9) Subject currently or within the past 12 months has required any form of treatment for depression (includes counseling/psychotherapy) or has a past medical history of mania, hypomania or bipolar disorder
10) In the 2 weeks prior to the screening visit, subject has received SSRIs, tricyclic antidepressants, tryptophan, lithium or St John’s Wort for any reason
11) In the 2 weeks prior to screening, subject has received a drug known to have significant interactions with SSRIs. These include but are not limited to: Anticoagulants, reversible inhibitors of monoamine oxidase type A (RIMAs), irreversible monoamine oxidase inhibitors (MAOIs) for any reason
12) Subject has a condition for which use of SSRIs is contraindicated or cautioned, such as: a) history of narrow angle glaucoma b) history of uncontrolled epilepsy c) history of bleeding disorders d) clinically significant (severe) renal or hepatic impairment.
13) Subject has any clinically significant abnormalities on screening physical examination, ECG, or safety laboratory tests (e.g. significant hematuria). Inclusion of subjects with abnormalities of doubtful significance must be discussed with the Pfizer representative prior to enrollment
14) Subject has received an experimental, non-approved drug within the past 30 days
15) Subject has a history of severe drug allergies or hypersensitivity or multiple adverse drug reactions
16) Subject intends to donate blood or blood products during the period of the study or within 1 month

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to model the dose response of UK-390,957 at week 8 and to define the least effective dose in the =2 minutes population, based on Intervaginal Ejaculatory Latency Time as the primary endpoint. ;Secondary Objective: The key secondary objectives of the study are to demonstrate the superiority of one or more doses of UK-390,957 versus placebo at Week 8 in the IELT response in the =2 minutes population and to model the dose response of UK-390,957 at Week 8 and to define the least effective dose in the =1 minute population.;Primary end point(s): Intravaginal ejaculatory latency time (IELT) as measured by the timer at week 8

Secondary Outcome Measures

Name	Time	Method

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