A phase IIb, multicentre, randomised, double-blind, placebo-controlled study, with open-label follow on, to evaluate the efficacy, safety and tolerability of PSD502 in subjects with premature ejaculation (PE)

Plethora Solutions Ltd (UK)0 个研究点目标入组 256 人开始时间: 2009年3月27日最近更新: 2019年3月18日

适应症

试验速览

•Current information as of 28/01/2010:
•A subject will be considered suitable for the study if he fulfills all of the following criteria:
•1. Willing and able to provide written informed consent
•2. Male, aged 18 years and over
•3. Diagnosed with PE according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) crietria and International Society for Sexual Medicine (ISSM) definition
•4. Diagnosed with lifelong PE
•5. Acceptable response to screening Premature Ejaculation Profile (PEP)
•6. Subject must be in a stable heterosexual and monogamous relationship and their 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 fulfills all of the following criteria:
•1. Willing and able to provide written informed consent
•2. Male, aged 18 years and over
•3. Diagnosed with PE
•4. Acceptable response to screening Premature Ejaculation Profile (PEP)
•5. Subject must be in a stable heterosexual and monogamous relationship and their partner must provide consent
•6. Acceptable sexual encounters in the baseline period

•A subject, or his sexual partner where stated, who fulfil 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 (G6PD) deficiency or use of medications that would increase susceptibility to methemoglobinaemia
•12. Subject, or his sexual partner, uses class I (e.g. mexiletine, tocainide) or III (e.g. amiodarone, sotalol) anti-arrhythmic drugs

发起方

Plethora Solutions Ltd (UK)