Diethylstilbestrol Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 297

Clinical Trials

Several Phase II and Phase III clinical trials, sponsored by both academic medical centers and pharmaceutical companies, have evaluated diethylstilbestrol for the treatment of prostatic neoplasms, including metastatic castration-resistant and advanced androgen-independent prostate cancer. All of these completed studies investigated diethylstilbestrol in combination regimens with docetaxel or corticosteroid therapy. Together, they provide key data regarding the compound's clinical utility and pharmacodynamic parameters in advanced prostate malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02217566	COMPLETED	Prostatic Neoplasms	Janssen Research & Development, LLC	2014-09-23	PHASE2
NCT00136526	COMPLETED	Prostate Cancer	University of Washington	2002-12	PHASE2
NCT00316927	COMPLETED	Prostate Cancer	St. Bartholomew's Hospital	2002-12	PHASE3

(data from https://clinicaltrials.gov, updated on 2020-01-13)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Diethylstilbestrol is a synthetic nonsteroidal estrogen that binds to estrogen receptors, suppressing follicle-stimulating hormone secretion from the anterior pituitary and altering systemic endocrine feedback loops. This suppressive action reduces hormone-dependent signaling and inhibits tumor cell proliferation, providing therapeutic relevance in the management of prostatic neoplasms such as metastatic castration-resistant prostate cancer.

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>).