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 |
To evaluate the safety and toleration of UK-390,957 administered as required by men withPremature ejaculation who successfully complete 1 of the following Pfizer sponsored trials:A3871022, A3871027 or A3871029. Sustained efficacy will be evaluated after 12, 24 and52 weeks of open-label therapy. |
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E.2.2 | Secondary objectives of the trial | |
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 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. |
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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 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety 1. Will be determined by laboratory testing (only clinically significant laboratory abnormalities will be summarized). 2. Adverse events will be monitored. Serious adverse events, discontinuations due to adverse events during the study and following withdrawal will be summarized. 3. Adverse events will be considered with respect to frequency of drug use. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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 | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
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 | Yes |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |