E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036596 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to investigate the safety and efficacy of the UK-390,957 individual flexible dose group (including doses up to 10 mg) compared to placebo. Efficacy will be assessed using IELT at Week 8 and adverse events will be summarized by treatment arm. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study will include, The comparison of responder rates (based on a ³2 fold increase in IELT from baseline) between the flexible dose arm and placebo at Week 8. Modelling the individual dose response. Assessment of patient reported outcomes listed under secondary endpoints on page 3 of the protocol. A diagnostic tool that is currently under development for assessing premature ejaculation will also be included for completion at screening. The resulting data will be used to further validate the tool. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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 intends to donate blood or blood products during the period of the study or within 1 month of the study’s completion. 17. Subject has a history of drug abuse within the past 2 years. 18. Subject has any medical or psychological condition or social circumstances that would impair his ability to participate reliably in the study. 19. Subject who in the investigator’s judgment is not a suitable candidate for this study for whatever reason. 20. Subject has been previously randomized in any other clinical trial with UK-390,957. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Intra-vaginal Ejaculatory Latency Time (IELT) as measured by the timer.The IELT will be calculated for every attempt of sexual intercourse during the 4-week run-in and8-week treatment period. The baseline IELT measurement for each subject will be calculated asthe mean IELT of all attempts during the run-in period. The Week 4 IELT value for each subjectwill be calculated as the mean of the IELT measurements of all on-treatment attempts in Weeks 1to 4 of treatment. The Week 8 IELT value for each subject will be calculated as the mean of theIELT measurements of all on-treatment attempts in Weeks 5 to 8 of treatment. The primary endpoint will be the log transform of the Week 8 mean IELT. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |