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

Active, not recruiting

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

• Registration Number: EUCTR2004-004150-51-GB
• Lead Sponsor: Pfizer Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-22
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Male
• Target Recruitment: 138

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
1. Subject is an adult male 18 years of age or over.
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 3 of the protocol).
4. Subject has a stable, monogamous, heterosexual relationship and has been 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 and Visit 3 to Visit 4).
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) 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 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.
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 glaucomab. history of uncontrolled epilepsyc. history of bleeding disordersd. 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 month.
15. Subject has a history of severe drug allergies or hypersensitivity or multiple adverse drug reactions.
16. Subject intend

Study & Design

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