The efficacy, safety and tolerability of PSD502 in subjects with premature ejaculation (PE)

Phase 2

Completed

• Conditions: Premature ejaculation; Mental and Behavioural Disorders; Sexual dysfunction, not caused by organic disorder or disease

• Registration Number: ISRCTN57186091
• Lead Sponsor: Plethora Solutions Ltd (UK)

Brief Summary

2010 results in: https://www.ncbi.nlm.nih.gov/pubmed/20584124 [added 20/02/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-27
• Study Completion: 2009-10-14
• Last Update Posted: 18 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 256

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:
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

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
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified