EUCTR2007-003171-39-CZ进行中（未招募）1 期
A phase III, multi-centre, randomized, double-blind, placebo-controlled study, with open-label follow on, to evaluate the efficacy, safety and tolerability of PDS502 in subjects with Premature Ejaculation (PE)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1.Willing and able to provide written informed consent.
- •2.Male and aged 18 years and over.
- •3.Diagnosed with PE according to DSM IV criteria.
- •4.Diagnosed with PE according to the ISSM definition, 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.
- •5. Subject has lifelong PE.
- •6. Subject response to Screening visit 1 PEP as follows:
- •a.Perceived control over ejaculation of ‘Poor’ or ‘Very poor’
- •b.Personal distress related to ejaculation of ‘Quite a bit’ or ‘Extremely’
- •c.Interpersonal difficulty related to ejaculation of ‘Quite a bit’ or ‘Extremely’
- •d.Satisfaction with sexual intercourse of ‘Poor’ or ‘Very poor’.
- •7.Subject must be in a stable heterosexual and monogamous relationship of at least 3 months duration with this partner.
- •8.Subject has at least documented 3 sexual encounters in the Baseline period.
- •9.IELT = 1 minute in at least 2 of the first 3 sexual encounters in the Baseline period.
- •10.The subject’s 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
排除标准
- •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 IIEF5 score of =21, unless the low score is entirely related to PE symptoms in the opinion of the Investigator.
- •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:
- •-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 received any treatment for PE e.g. anti-depressant therapy, local anesthetic spray, intra-cavernosal injection or psychotherapy within 4 weeks of Screening.
- •7.Subject, or his sexual partner, has a current history of alcohol or drug abuse, in the opinion of the Investigator.
- •8.The subject, or his sexual partner, is unlikely to understand or be able to comply with study procedures, for whatever reasons.
- •9.Subject or his sexual partner has known drug sensitivity to amide-type local anesthetics.
- •10.Subjects with pregnant partners.
- •11.Subject with sexual partners of child-bearing potential and not using appropriate contraception [hormonal contraception or intra-uterine device (IUD) during double-blind part of study; hormonal contraception or IUD or condom during open-label part of study].
- •12.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).
- •13. Subject, or his sexual partner, uses class I (e.g. mexiletine, tocainide) or III (e.g. amiodarone, sotalol) anti-arrhythmic drugs.
研究者
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