ISRCTN77251669
Completed
Phase 4
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 sites24 target enrollmentFebruary 10, 2023
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Erectile Dysfunction (ED) post radical prostatectomy
- Sponsor
- RestoriT Ltd
- Enrollment
- 24
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Not specified
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