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 | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036596 |
E.1.2 | Term | Premature ejaculation |
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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 determine the effect of PSD502 on the Index of Premature Ejaculation (IPE) and intravaginal ejaculatory latency time (IELT). |
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E.2.2 | Secondary objectives of the trial |
To evaluate safety and tolerability of PSD502 in subjects with PE, and their sexual partners.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Willing and able to provide written informed consent. 2.Male and aged 18 years and over. 3.Diagnosed with PE according to DSM IV criteria. 4. Diagnose with PE according to ISSM definition, that is, he ejaculates always ot nearly always prior to or within about one minute of vaginal penetration; and is unable to delay ejaculation on all or nearly all vaginal penetrations; and experiences negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy. 5. Subject has lifelong PE. 6. Subject response to Screening visit 1 PEP as follows: a.Perceived control over ejaculation of ‘Poor’ or ‘Very poor’ b.Personal distress related to ejaculation of ‘Quite a bit’ or ‘Extremely’ c.Interpersonal difficulty related to ejaculation of ‘Quite a bit’ or ‘Extremely’ d.Satisfaction with sexual intercourse of ‘Poor’ or ‘Very poor’. 7.Subject must be in a stable heterosexual and monogamous relationship of at least 3 months duration with this partner. 8.Subject has at least documented 3 sexual encounters in the Baseline period. 9.IELT ≤ 1 minute in at least 2 of the first 3 sexual encounters in the Baseline period. 10.The subject’s partner must provide written informed consent, be aged 18 years or over and willing to comply with the study procedures.
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E.4 | Principal exclusion criteria |
1.Subject, or his sexual partner, has received an investigational (non-registered) drug within 30 days of Screening. 2.Subject has erectile dysfunction, defined as an IIEF5 score of ≤21, unless the low score is entirely related to PE symptoms in the opinion of the Investigator. 3.The subject, or his sexual partner, has a physical or psychological condition that would prevent them from undertaking the study procedures, including, but not limited to, the following: -Urological disease (e.g. prostatitis, urinary tract infection) or genito-urinary surgery within 8 weeks of Screening -Ongoing significant psychiatric disorder (e.g. bipolar disease, depression / anxiety disorder or schizophrenia) not controlled by medication. 4.Subject has safety testing abnormalities at the Screening Visit, in particular liver function tests, that are indicative of a medical condition that would preclude further participation in the opinion of the Investigator. 5.Subjects taking tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs) or selective serotonin reuptake inhibitors (SSRIs), for indications other than PE, where the dose has been changed within 4 weeks of Screening and it is planned that the dose will change during the double-blind treatment period. 6.Subject has received any treatment for PE e.g. anti-depressant therapy, local anesthetic spray, intra-cavernosal injection or psychotherapy within 4 weeks of Screening. 7.Subject, or his sexual partner, has a current history of alcohol or drug abuse, in the opinion of the Investigator. 8.The subject, or his sexual partner, is unlikely to understand or be able to comply with study procedures, for whatever reasons. 9.Subject or his sexual partner has known drug sensitivity to amide-type local anesthetics. 10.Subjects with pregnant partners. 11.Subject with sexual partners of child-bearing potential and not using appropriate contraception [hormonal contraception or intra-uterine device (IUD) during double-blind part of study; hormonal contraception or IUD or condom during open-label part of study]. 12.Subject, or his sexual partner, has a history of Glucose-6-Phosphate Dehydrogenase (G-6-PD) deficiency or use of medications that would increase susceptibility to methemoglobinemia (e.g. anti-malarial agents). 13. Subject, or his sexual partner, uses class I (e.g. mexiletine, tocainide) or III (e.g. amiodarone, sotalol) anti-arrhythmic drugs.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variables are the: •Change in mean IELT from Baseline to during the 3 months of double-blind treatment •Change in the IPE domain of ejaculatory control from Baseline to month 3 •Change in the IPE domain of sexual satisfaction from Baseline to month 3.
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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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
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 | No |
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
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |