Estramustine phosphate sodium Clinical Trials

Size	Price	Qty
25mg	USD 97
1g	USD 970

Clinical Trials

Multiple clinical trials are currently associated with this compound, investigating conditions including heart failure, outpatient prescription management issues, and COVID-19. Sponsored by academic and health system institutions such as the University of Vermont and Methodist Health System, along with pharmaceutical sponsors like Boehringer Ingelheim, these studies operate under unspecified phases or are classified as not applicable for phase designation. Several clinical trials currently maintain an active, not recruiting status while evaluating functional capacity, pharmacy prescriptive authority, and long-term patient outcomes.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05350202	Active not recruiting	Heart Failure	Boehringer Ingelheim	2022-12-15	--
NCT06222424	Active not recruiting	Outpatient Prescription Issues	Methodist Health System	2021-11-01	Not Applicable
NCT04892797	Active not recruiting	Covid19	University of Vermont	2021-02-03	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Estramustine phosphate sodium undergoes metabolic cleavage to release estramustine, which binds directly to microtubule-associated proteins and tubulin, thereby disrupting microtubule dynamics and arresting mitosis in target cells. This antimicrotubule and antigonadotrophic action suppresses cellular proliferation and hormonal signaling, providing therapeutic relevance evaluated across clinical trial settings including heart failure, outpatient prescription management, and COVID-19 outcomes.

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>).