ISRCTN77251669已完成4 期
An open label, pilot study to determine the effect of in-centre and at-home administration intra-cavernosal injections of Invicorp on male Erectile Dysfunction (ED) post radical prostatectomy
RestoriT Ltd0 个研究点目标入组 24 人开始时间: 2023年2月10日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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. Willing and able to provide written informed consent.
- •2. Adult (18 years or older), male subjects with diagnosis of prostate cancer and scheduled radical prostatectomy either nerve sparing and non-nerve sparing.
- •3. In generally good health in the opinion of the Investigator.
- •4. Willing and able to comply with all study procedures in the opinion of the Investigator.
排除标准
- •1. History of a significant medical condition that would preclude further study participation, in the opinion of the Investigator.
- •2. Symptoms suggestive of COVID-19 infection and positive PCR test.
- •3. Undergone radiotherapy post radical prostatectomy.
- •4. Received chemotherapy post radical prostatectomy.
- •5. Experiencing significant incontinence post operatively.
- •6. Use of PDEV inhibitors within 1 month prior to the screening visit.
- •7. History of allergy to aviptadil or phentolamine mesilate or any of the other ingredients of the study medicine Invicorp.
- •8. Current diagnosis or history of leukaemia (cancer of the blood), multiple myeloma (bone cancer) or sickle cell anaemia or trait (a blood disease).
- •9. Currently taking anticoagulant agents such as warfarin or heparin, (except low molecular weight heparin given subcutaneously for venous thromboembolism prophylaxis), including oral blood thinning medicines such as dabigatran, rivaroxaban, apixaban within 1 month prior to the screening visit.
- •10. Anatomical deformation of the penis, such as angulation, history of Peyronie’s disease or abnormal fibrous tissue in the erectile tissue of the penis (cavernosal fibrosis).
- •11. Subject has penile implant.
- •12. Men for whom sexual activity is not advisable or is contraindicated due to organic disease.
- •13. Positive for hepatitis B, hepatitis C, or HIV infection.
- •14. Safety testing abnormalities at the Screening Visit, that are indicative of a medical condition and that would preclude further participation, in the opinion of the Investigator.
- •15. Subject unwilling to perform study drug home administration.
- •16. History of alcohol or drug abuse within 1 year prior to the Screening Visit.
- •17. Use of an investigational (non-registered) drug within 30 days before the first Screening Visit
研究者
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