EUCTR2014-005571-89-PL进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, home use, cross-over clinical trial of topically-applied glyceryl trinitrate (GTN) for the treatment of Erectile Dysfunction - Clinical trial of topical GTN for treatment of Erectile dysfunction
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 192
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Subject is a male aged between 18 and 70 years of age inclusive, at screening.
- •2. Confirmed self-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. The IIEF question 1-5 and 15 will be used to determine pre-screening eligibility for the subject. A score of 25 or less will be acceptable for inclusion to the run-in-period.
- •4. Subject answers yes” to the question regarding the presence of residual erectile function 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?”
- •5. Subject has been involved in a continuous heterosexual relationship for at least 6 months prior to screening.
- •6. Documented written informed consent from both subject and his female partner.
- •7. If the male subject's female partner is of childbearing potential from the time of first sexual intercourse attempt during the run-in period until the last administration of study treatment they must agree to use adequate methods of contraception as listed in Protocol
- •8. Subject and their female partner are capable of understanding and complying with the requirements of the protocol and must have signed the informed consent form prior to participation of any study-related procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •1. Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological, psychiatric, or other disease.
- •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.
- •3. Any presence of a symptomatic, active urinary tract infection diagnosed by the PI or delegate at screening (subjects may be enrolled 7 days after completion of antibiotic therapy with a clinical cure; if a subject develops a urinary tract infection after screening, they may be continued in the study if they receive appropriate antibiotic therapy).
- •4. Any presence of chronic indwelling urethral catheterization or penile anatomical abnormalities (e.g. penile fibrosis) that would significantly impair erectile function.
- •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 blood pressure.
- •10. Hypersensitivity to GTN or to any of the excipients or idiosyncratic reactions to other organic nitrates.
- •11. Concomitant treatment with sildenafil citrate, tadalafil, vardenafil and with NO donors, such as other GTN products, isosorbide dinitrate and amyl or butyl-nitrite.
- •12. Any treatment with acetyl cysteine within 6 months.
- •13. Any treatment with dihydroergotamine within 6 months.
- •14. Postural hypotension, hypotension or uncorrected hypovolaemia as the use of GTN in such states could produce severe hypotension or shock.
- •15. Increased intracranial pressure (e.g. head trauma or cerebral haemorrhage) or inadequate cerebral circulation.
- •16. Any history of migraine or recurrent headache.
- •17. Aortic or mitral stenosis.
- •18. Hypertrophic obstructive cardiomyopathy.
- •19. Constrictive pericarditis or pericardial tamponade.
- •20. Marked anaemia within 6 months.
- •21. Closed-angle glaucoma.
- •22. Subjects with nursing partners, known pregnant partners or wish to become pregnant during the course of the study.
- •Please refer to Protocol for detailed list of exclusion criterias.
研究者
相似试验
进行中（未招募）
Unknown
actoSpore® as an adjuvant in the treatment of Bacterial VaginosisCTRI/2023/05/052560Sami Sabinsa Group Limited
进行中（未招募）
1 期
Efficacy and safety of dexketoprofen trometamol and tramadol hydrochloride combination on moderate to severe acute pain in patients with acute low back paiow back painMedDRA version: 21.0Level: LLTClassification code 10024891Term: Low back painSystem Organ Class: 100000004859EUCTR2019-003656-37-HRMenarini International Operations Luxembourg SA510
进行中（未招募）
不适用
A randomized, double-blind, placebo-controlled, parallel group study to investigate the safety and tolerability of 14-days treatment with an inhaled dose of QMF149 (500/800) in mild to moderate asthmatic patients.asthmaEUCTR2007-004608-11-FRovartis Pharma Services AG28
已完成
不适用
Boswellia serrata extract 200 mg capsules in subject with Irritable Bowel Syndrome.CTRI/2019/11/022190Inventia Healthcare Limited50
进行中（未招募）
不适用
A randomized, double-blind, placebo-controlled, parallel group study to evaluate the effects of a 4-week treatment of 30 mg b.i.d BIBW 2948 BS (inhalation powder, hard capsule for HandiHaler®) on epithelial mucin stores and the safety and efficacy in COPD patients with symptoms associated with chronic bronchitis - Effects of BIBW 2948 on epithelial muciEUCTR2006-001975-40-IEBoehringer Ingelheim Limited60