EUCTR2017-000960-14-HU进行中（未招募）1 期
A Phase III, dose ranging, multi-centre, randomised, double blind, placebo controlled, home use, parallel group clinical trial of topically-applied glyceryl trinitrate (GTN) for the treatment of erectile dysfunction (ED) with an open label extension
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
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.Subject is a male aged between 18 and 70 years inclusive, at screening
- •2.Confirmed clinical diagnosis of ED for more than 3 months according to the NIH Consensus Statement (‘the inability to achieve or maintain penile erection sufficient for satisfactory sexual performance at least once’)
- •3.Subject answers ‘yes’ to the question regarding the presence of residual EF over the past 3 months: ‘At home over the past 3 months, have you experienced at least some growth of your penis in response to: (1) mechanical stimulation by yourself or your partner, or (2) visual stimulation?’
- •4.Subject has been involved in a continuous heterosexual relationship for at least 6 months prior to screening
- •5.Documented written informed consent from both subject and his female partner
- •6.If the male subject's female partner is of childbearing potential from the time of first sexual intercourse attempt during the screening period until the last administration of study treatment, then the couple must have been using a medically acceptable form of contraception for at least 3 months prior to entering the study, and agree to continue such use for at least 1 month after the last study drug administration
- •Acceptable methods of contraception are listed below; it should be noted that condoms, femidoms, diaphragms, caps or hormone rings are not permitted as a form of contraception in this study:
- •?Surgical sterilisation of the male partner (vasectomy with documentation of azoospermia if possible)
- •?The female partner has undergone documented tubal ligation (female sterilisation)
- •?The female partner uses combined hormone injectables
- •?The female partner uses medically prescribed hormonal implants
- •?The female partner has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS)
- •?The female partner uses combined oral contraceptives
- •?The female partner uses progesterone only contraceptives
- •?The female partner uses combined hormonal patches
- •Other than for male/female sterilisation, if any of these above listed methods are being used then their effectiveness must be determined by the PI or their delegate, taking into consideration the compliance and tolerance of the female partner with this method of contraception.
- •Subjects who are or wish to become pregnant will not be included in the study.
- •7.Subject and his female partner are capable of understanding and complying with the requirements of the protocol and must have signed the ICF prior to participation in any study related procedures
- •8.Low IIEF-EF scores (= 25) during the screening period
- •To continue in the open-label extension phase of the study, subjects must meet the following inclusion criteria at the follow-up visit of the double-blind phase (Visit 6):
- •1.Subject and his female partner complete the double-blind phase
- •2.Subject and his female partner were compliant to study procedures during the double blind phase
- •3.Documented written informed consent from both subject and his female partner
- •4.If the male subject's female partner is of childbearing potential from the time of first sexual intercourse attempt during the screening period until the last administration of study treatment, then the couple must have been using a medically acceptable form of contraception for at least 3 months prior to entering the study, and agree to continue such use for at least 1 month after the last study drug administration
- •Acceptable methods of contraception ar
排除标准
- •1.Any significant or serious cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease which, in the opinion of the PI, renders the subject unfit to take part in the study
- •2.Subject has any history of an unstable medical or psychiatric condition or using any medication that, in the opinion of the PI, is likely to affect the subject’s ability to complete the study or precludes the subject’s participation in the study
- •Certain concomitant medications; e.g. other vasodilators, calcium channel blockers, angiotensin converting enzyme (ACE) inhibitors, beta blockers, diuretics, anti hypertensives, tricyclic anti depressants and major tranquillisers, as well as the consumption of alcohol, may potentiate the BP lowering effects of MED2005; at PI's discretion
- •3.Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or their delegate at screening or during the study
- •4.Any presence of chronic indwelling urethral catheterisation or penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair EF
- •5.Any history of operations for Peyronie’s disease
- •6.Primary hypoactive sexual desire or any history of hypogonadism
- •7.Any history of radical prostatectomy
- •8.Any history of severe/uncontrolled diabetes
- •9.Subjects taking two or more anti hypertensives for the treatment of BP
- •10.Hypersensitivity to GTN or to any of the excipients, or idiosyncratic reactions to other organic nitrates
- •11.Concomitant treatment with PDE 5 inhibitors
- •12.Subjects taking Alpha blockers
- •13.Subjects receiving testosterone pellets
- •14.Any penile surgery except circumcision
- •15.Any treatment with acetyl cysteine within 6 months
- •16.Any treatment with dihydroergotamine within 6 months
- •17.Postural hypotension, hypotension or uncorrected hypovolaemia
- •18.Increased intracranial pressure (e.g. head trauma or cerebral haemorrhage) or inadequate cerebral circulation
- •19.Any history of migraine or recurrent headache
- •20.Aortic or mitral stenosis
- •21.Hypertrophic obstructive cardiomyopathy
- •22.Constrictive pericarditis or pericardial tamponade
- •23.Closed-angle glaucoma
- •24.Subjects with nursing partners, known pregnant partners or with partners who wish to become pregnant during the course of the study
- •25.Confirmed positive results from urine drug screen or from the alcohol breath test at screening
- •26.Subject has recent (last 12 months) clinical evidence of alcoholism or drug abuse.
- •27.Subject has a positive screen for hepatitis B, consisting of HBsAG, hepatitis C antibody, and HIV
- •28.Any clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations conducted at screening or on admission
- •29.Subjects unwilling to cease use of vacuum devices, intracavernosal injections, PDE-5s or other therapy for ED for the entire course of the study
- •30.Unwillingness of the subject or their partner to agree to make the required attempts at sexual intercourse during treatment period
- •31.Any history of unresponsiveness to PDE 5 treatment or significant side effects, excluding visual disturbances, with PDE 5s
- •32.Fewer than 4 attempts at sexual intercourse during the screening period
- •33.Subjects or their partners who are illiterate or are unable to understand the language in which the questionnaires are available
- •34.Subject has rece
研究者
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