A Phase II, multi-centre, double-blind, randomised, placebo-controlled, 4-way cross-over, dose-range finding study to evaluate efficacy and safety and tolerability of PSD502 in subjects with premature ejaculation (PE).
- Conditions
- Premature EjaculationMedDRA version: 9.1Level: PTClassification code 10036596Term: Premature ejaculation
- Registration Number
- EUCTR2008-003650-15-CZ
- Lead Sponsor
- Plethora Solutions Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 40
1. Has provided written informed consent.
2. Male and aged 18 years and over.
3. Diagnosed with lifelong PE according to ISSM criteria, that is, he ejaculates always or 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.
4. Subject must be in a stable heterosexual and monogamous relationship of at least 3 months duration with his partner.
5. Subject has at least documented 1 sexual encounter in the Baseline period.
6. IELT = 1 minute in at least 1 sexual encounter in the Baseline period.
7. Willing and able to comply with the study procedures.
8. The subject’s sexual partner must provide written informed consent, be aged 18 years or over and willing to comply with the study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 International Index of Erectile Function-5 (IIEF-5) score of =21, unless the low score is entirely related to PE symptoms in the opinion of the Investigator.
3. Subject, or his sexual partner, has any 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 previously received treatment with PSD502 for PE.
7. Subject has received any treatment for PE e.g. anti-depressant therapy, local aesthetic spray, intra-cavernosal injection or psychotherapy within 4 weeks of Screening.
8. Subject, or his sexual partner, has a current history of alcohol or drug abuse, in the opinion of the Investigator.
9. Subject, or his sexual partner, has known drug sensitivity to amide-type local anaesthetics.
10. Subjects with pregnant partners or those not using adequate forms of contraception. These include vasectomy, female hormonal contraception, intra-uterine device (IUD) or cap plus spermicide. The use of condoms is not permitted throughout the baseline and treatment period.
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).
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of 3 different doses (3 mg, 30 mg and 53 mg) of PSD502 on Intra-vaginal Ejaculatory Latency Time (IELT),;Secondary Objective: To assess the safety and tolerability of 3 different doses (3 mg, 30 mg and 53 mg) of PSD502.;Primary end point(s): The primary efficacy variable is change from baseline in mean IELT.
- Secondary Outcome Measures
Name Time Method