Vardenafil hydrochloride Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Numerous clinical trials spanning early Phase 1 through Phase 4 evaluate vardenafil hydrochloride for erectile dysfunction, pulmonary arterial hypertension, Raynaud syndrome, and sexual dysfunction in patients with spinal cord injury or type 2 diabetes mellitus. Spearheaded by industry sponsors including Bayer, GlaxoSmithKline, and Respira Therapeutics alongside academic institutions such as the Rabin Medical Center and University of Cologne, these studies encompass completed, terminated, and unknown recruitment statuses. Key evaluations have assessed safety during concomitant alpha-blocker therapy and exercise parameters in pulmonary arterial hypertension.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06491108	UNKNOWN	Enlarged Prostate With Lower Urinary Tract Symptoms	Tanta University	2024-06-01	PHASE3
NCT04266197	COMPLETED	Pulmonary Arterial Hypertension	Respira Therapeutics, Inc.	2020-09-25	PHASE2
NCT06860399	COMPLETED	PPHN	Damascus University	2023-05-01	PHASE1; PHASE2
NCT05343637	COMPLETED	Pulmonary Arterial Hypertension	Respira Therapeutics, Inc.	2019-07-30	PHASE2
NCT05567367	COMPLETED	Healthy Volunteer	Respira Therapeutics, Inc.	2018-07-31	PHASE1
NCT03102398	UNKNOWN	Erectile Dysfunction	Tritech Biopharmaceuticals Co., Ltd.	2017-03-31	PHASE1; PHASE2
NCT02344823	UNKNOWN	Cirrhosis; Erectile Dysfunction	Medical University of Vienna	2012-06	PHASE4
NCT02450188	COMPLETED	Erectile Dysfunction	University of Florence	2012-03	PHASE4
NCT02279992	TERMINATED	Glioma; Brain Neoplasms; Brain Metastasis	Cedars-Sinai Medical Center	2012-03-27	EARLY_PHASE1
NCT01649739	UNKNOWN	Pulmonary Arterial Hypertension	Rabin Medical Center	2012-09	PHASE4
NCT02219646	COMPLETED	Type 2 Diabetes Mellitus (T2DM); Endothelial Dysfunction; Erectile Dysfunction	Azienda USL Modena	2010-03	PHASE2
NCT01002534	TERMINATED	Cystic Fibrosis	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	2011-10	PHASE2
NCT01348880	COMPLETED	Erectile Dysfunction	Bayer	2011-05	PHASE1
NCT01260285	COMPLETED	Ischemia-reperfusion Injury.	McGuire Research Institute	2010-12	PHASE1
NCT01168817	COMPLETED	Erectile Dysfunction	Bayer	2010-08	PHASE2
NCT00498680	UNKNOWN	Impotence	Rambam Health Care Campus	2007-03	PHASE4
NCT01084187	COMPLETED	Erectile Dysfunction; Arterial Hypertension; Endothelial Dysfunction	Hospital Universitario Pedro Ernesto	2010-01	PHASE4
NCT01110590	COMPLETED	Erectile Dysfunction	Bayer	2010-01	PHASE1
NCT00705588	UNKNOWN	Pulmonary Arterial Hypertension	Rabin Medical Center	2008-08	PHASE4
NCT00718952	COMPLETED	Pulmonary Hypertension	Tongji University	2008-07	PHASE3
NCT00738400	COMPLETED	Erectile Dysfunction; Metabolic Syndrome	Bayer	2008-11	PHASE4
NCT01291199	COMPLETED	Raynaud Syndrome	University of Cologne	2006-11	PHASE2; PHASE3
NCT00725790	UNKNOWN	Erectile Dysfunction	China Rehabilitation Research Center	2008-08	PHASE4
NCT00655629	COMPLETED	Erectile Dysfunction	Bayer	2008-04	PHASE3
NCT00631969	COMPLETED	Erectile Dysfunction	Bayer	2008-04	PHASE3
NCT00478881	COMPLETED	Overactive Bladder; Detrusor Overactivity	Bayer	2007-08	PHASE2
NCT00461123	COMPLETED	Prostatic Hypertrophy, Benign	Bayer	2007-03	PHASE2
NCT00853840	COMPLETED	AIDS	ViiV Healthcare	2008-04	PHASE4
NCT01207947	Completed	Erectile Dysfunction	Bayer	2007-10	--
NCT00492635	COMPLETED	Erectile Dysfunction; Sexual Dysfunction, Physiological	Bayer	2004-12	PHASE3
NCT00909233	Completed	Erectile Dysfunction	Bayer	2007-08	--
NCT00379756	COMPLETED	Erectile Dysfunction	GlaxoSmithKline	2006-05-22	PHASE4
NCT00655590	COMPLETED	Erectile Dysfunction	Bayer	2005-01	PHASE4
NCT00665054	COMPLETED	Erectile Dysfunction	Bayer	2004-08	PHASE4
NCT00663728	COMPLETED	Erectile Dysfunction	Bayer	2004-09	PHASE4
NCT00665340	COMPLETED	Erectile Dysfunction	Bayer	2004-07	PHASE4
NCT00668096	COMPLETED	Erectile Dysfunction	Bayer	2004-05	PHASE4
NCT00663130	COMPLETED	Erectile Dysfunction	Bayer	2004-04	PHASE4
NCT00668109	COMPLETED	Erectile Dysfunction	Bayer	2003-12	PHASE3
NCT00661700	COMPLETED	Erectile Dysfunction	Bayer	2003-04	PHASE3
NCT00668135	COMPLETED	Erectile Dysfunction	Bayer	2003-03	PHASE4
NCT00657644	COMPLETED	Erectile Dysfunction	Bayer	2003-08	PHASE3
NCT00654914	COMPLETED	Erectile Dysfunction	Bayer	2003-05	PHASE3
NCT00661115	COMPLETED	Erectile Dysfunction	Bayer	2003-05	PHASE3
NCT00654680	COMPLETED	Erectile Dysfunction	Bayer	2002-10	PHASE3
NCT00661596	COMPLETED	Erectile Dysfunction	Bayer	2003-05	PHASE3
NCT00661219	COMPLETED	Erectile Dysfunction; Depression	Bayer	2002-12	PHASE3
NCT00668018	COMPLETED	Erectile Dysfunction	Bayer	2003-01	PHASE3
NCT00668057	COMPLETED	Erectile Dysfunction	Bayer	2002-12	PHASE3
NCT00656188	COMPLETED	Erectile Dysfunction	Bayer	2002-10	PHASE2; PHASE3
NCT00652262	COMPLETED	Erectile Dysfunction; Sexual Dysfunction; Spinal Cord Injury	Bayer	2004-03	PHASE3
NCT00662441	COMPLETED	Erectile Dysfunction	Bayer	2003-09	PHASE4
NCT00667979	COMPLETED	Erectile Dysfunction	Bayer	2004-09	PHASE4
NCT00663845	COMPLETED	Erectile Dysfunction	Bayer	2006-05	PHASE4
NCT00786253	COMPLETED	Erectile Dysfunction	Bayer	2005-10	PHASE2
NCT00678704	COMPLETED	Erectile Dysfunction; Diabetes Mellitus	Bayer	2004-01	PHASE3
NCT00682019	COMPLETED	Erectile Dysfunction	Bayer	2003-12	PHASE3
NCT00657839	COMPLETED	Benign Prostatic Hyperplasia	Bayer	2005-10	PHASE2
NCT00377793	COMPLETED	Sexual Dysfunction; Male Erectile Dysfunction	Bayer	2006-07	PHASE4
NCT00667966	COMPLETED	Erectile Dysfunction; Spinal Cord Injury	Bayer	2005-07	PHASE4
NCT00660998	COMPLETED	Erectile Dysfunction	Bayer	2003-02	PHASE4
NCT00681772	COMPLETED	Erectile Dysfunction	Bayer	2003-03	PHASE4
NCT00665496	COMPLETED	Erectile Dysfunction	Bayer	2003-06	PHASE3
NCT00517179	COMPLETED	Prostatic Hyperplasia; Impotence	Hospital Authority, Hong Kong	2006-04
NCT00658177	COMPLETED	Erectile Dysfunction	Bayer	2003-06	PHASE3
NCT00664833	COMPLETED	Erectile Dysfunction	Bayer	2004-05	PHASE4
NCT00461565	COMPLETED	Safety	Bayer	2005-02	PHASE4
NCT00661297	COMPLETED	Erectile Dysfunction	Bayer	2003-06	PHASE3
NCT00657033	COMPLETED	Erectile Dysfunction	Bayer	2003-10	PHASE3
NCT00668005	COMPLETED	Erectile Dysfunction	Bayer	2003-02	PHASE3
NCT00666809	COMPLETED	Tinnitus	Bayer	2006-10	PHASE2
NCT00663598	COMPLETED	Erectile Dysfunction	Bayer	2003-10	PHASE4

(data from https://clinicaltrials.gov, updated on 2024-07-08)

Check the Vardenafil hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vardenafil hydrochloride acts as a potent, selective inhibitor of phosphodiesterase-5 (PDE5), which blocks the hydrolysis of cyclic guanosine monophosphate (cGMP) and consequently elevates intracellular cGMP levels to induce vascular smooth muscle relaxation. This targeted enzymatic inhibition and subsequent vasodilation directly underlie its therapeutic efficacy in restoring erectile response and attenuating pulmonary vascular resistance in clinical conditions such as erectile dysfunction and pulmonary arterial hypertension.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).