ISRCTN57186091
Completed
Phase 2
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 sites256 target enrollmentMarch 27, 2009
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Plethora Solutions Ltd (UK)
- Enrollment
- 256
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
2010 results in: https://www.ncbi.nlm.nih.gov/pubmed/20584124 [added 20/02/2019]
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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