Premature ejaculation Urological and Genital Diseases Premature ejaculation
Conditions
Sponsors
Plethora Solutions Limited (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Current information as of 29/01/2010: A subject will be considered suitable for the study if he fulfils all of the following criteria: 1. Willing and able to provide written informed consent 2. Male and aged 18 years and over 3. Diagnosed with PE according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria and International Society for Sexual Medicine (ISSM) definition 4. Has lifelong PE 5. Acceptable response to baseline premature ejaculation profile (PEP) 6. Subject must be in a stable heterosexual and monogamous relationship and the partner must provide consent 7. Acceptable sexual encounters in the baseline period Initial information at time of registration: A subject will be considered suitable for the study if he fulfils all of the following criteria: 1. Willing and able to provide written informed consent 2. Male and aged 18 years and over 3. Diagnosed with PE 4. Acceptable response to baseline premature ejaculation profile (PEP) 5. Subject must be in a stable heterosexual and monogamous relationship and the partner must provide consent 6. Acceptable sexual encounters in the baseline period
Exclusion criteria
Exclusion criteria: A subject or his sexual partner where stated, who fulfils any of the following criteria will be excluded from the study: 1. Subject, or his sexual partner, has received an investigational (non-registered) drug within 30 days of screening 2. Subject has erectile dysfunction 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: 3.1. Urological disease 3.2. Ongoing significant psychiatric disorder not controlled by medication 4. Subject has safety testing abnormalities at the screening visit 5. Subjects taking excluded medications or receiving any treatment for PE 6. Subject, or his sexual partner, has a current history of alcohol or drug abuse 7. The subject, or his sexual partner, is unlikely to understand or be able to comply with study procedures, for whatever reasons 8. Subject, or his sexual partner, has known drug sensitivity to amide-type local anaesthetics 9. Subjects with pregnant partners 10. Subject with sexual partners of child-bearing potential and not using appropriate contraception 11. 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate efficacy of treatment with PSD502 compared with placebo in subjects with PE as measured by: 1. Changes in mean IELT from baseline to during three-month double-blind treatment 2. Changes in selected IPE domains from baseline to month three | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in selected IPE domains from baseline to three months 2. Proportion of subjects with short mean IELT during the three months of double-blind treatment 3. Change in mean IELT from baseline 4. Subject and partner PEP scores 5. Evaluation of the safety and tolerability of PSD502 compared with placebo in subjects with PE as measured by adverse event (AE) and serious adverse event (SAE) data for both the subject and his sexual partner, collected throughout the study | — |
Countries
Czech Republic, Hungary, Poland, United Kingdom
Outcome results
None listed