EUCTR2008-003650-15-CZActive, not recruitingPhase 1
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
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Plethora Solutions Ltd
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
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