Miconazole Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials have evaluated miconazole across distinct settings, all of which have reached completed status. A Phase III trial sponsored by Valerio Therapeutics evaluated the clinical efficacy and safety of a miconazole formulation in patients with HIV infections. Additionally, an unclassified study with Phase Not Applicable, sponsored by the University of Southern Denmark and Odense University Hospital, investigated miconazole uptake and its effects on estrogen-metabolizing enzymes in healthy human subjects.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00668538	Completed	Healthy	University of Southern Denmark\|Odense University Hospital	2008-04	Not Applicable
NCT00390780	Completed	HIV Infections	Valerio Therapeutics	2006-07	Phase 3

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Miconazole acts by inhibiting fungal 14α-demethylase, which blocks the biosynthesis of ergosterol and severely impairs fungal cell membrane structure and function. This disruption leads to altered membrane permeability, inhibition of cell growth, and fungal cell death, rendering it clinically effective in treating mucosal fungal complications in patients with HIV infections.

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>).