Estrone sulfate sodium Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Multiple clinical trials investigate the physiological roles and diagnostic or therapeutic applications of estrone derivatives and conjugates across conditions including gynecologic cancer, in vitro fertilization, hormone testing, and obesity. Conducted by various institutional and pharmaceutical sponsors, such as the Istanbul Training and Research Hospital, Olive Fertility Centre, and Manhattan Pharmaceuticals, these studies encompass Phase 2, observational, and unspecified trial phases. Recruitment statuses range from completed interventions evaluating adipose tissue hormone dynamics and urinary estrone glucuronide to trials with unknown status targeting obesity.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03258307	COMPLETED	Gynecologic Cancer	Istanbul Training and Research Hospital	2017-02-01
NCT00449202	UNKNOWN	Obesity	Manhattan Pharmaceuticals	2006-06	PHASE2
NCT00449254	UNKNOWN	Obesity	Manhattan Pharmaceuticals	2006-10	PHASE2

(data from https://clinicaltrials.gov, updated on 2019-08-06)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Estrone sulfate sodium acts as a primary circulating conjugated estrogen precursor that undergoes hydrolysis by steroid sulfatase to liberate free estrone, which then binds estrogen receptors to trigger downstream gene transcription and stimulate cellular proliferation. By functioning as a major systemic reservoir for active estrogen signaling, this precursor provides vital pathophysiological relevance to diagnostic hormone testing, reproductive medicine during in vitro fertilization, gynecologic cancer, and obesity-related metabolic research.

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>).