Estrone Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Multiple clinical trials evaluate estrone and related estrogenic signaling pathways across Phase 1, Phase 2, and non-interventional designs. Sponsored by academic institutions, medical centers, and pharmaceutical companies such as Dartmouth-Hitchcock Medical Center and Atossa Therapeutics, these studies target conditions including estrogen receptor-positive metastatic breast cancer, climacteric syndrome and menopause, secondary amenorrhea, gynecologic cancers, and obesity. Current recruitment statuses across these trials span from not yet recruiting and actively recruiting to completed and unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05900895	Not yet recruiting	Metastatic Breast Cancer	Mary D Chamberlin\|Dartmouth-Hitchcock Medical Center	2024-05	Phase 1
NCT06136208	Recruiting	Climacteric Syndrome\|Menopause\|Hypoestrogenism	Science Valley Research Institute\|Biòs Farmacêutica	2023-12-13	Not Applicable
NCT05974449	Recruiting	Breast Cancer Female	The First Affiliated Hospital with Nanjing Medical University	2023-08-24	Phase 2
NCT05967819	Recruiting	Amenorrhea Secondary	University of Colorado Colorado Springs	2023-08-09	Not Applicable
NCT05607004	Recruiting	Breast Neoplasms\|Invasive Breast Cancer\|Estrogen-receptor-positive Breast Cancer\|HER2-negative Breast Cancer	Atossa Therapeutics Inc.\|InClin	2023-02-14	Phase 2
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 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Estrone binds to estrogen receptors to modulate downstream transcriptional activation and gene expression, serving as a circulating steroid reservoir that converts into the potent metabolite estradiol to drive cellular proliferation and differentiation. This estrogen receptor-mediated signaling plays a pivotal role in reproductive biology and endocrine-dependent pathologies, providing key therapeutic relevance to clinical investigations in estrogen receptor-positive breast cancers, gynecologic malignancies, and climacteric syndrome.

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>).