Estradiol Cypionate Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

A Phase 1 clinical trial has evaluated the pharmacological profile of estradiol cypionate for contraception, assessing the comparative bioavailability of injectable suspension formulations combining the compound with medroxyprogesterone acetate. Sponsored by industry partners Galeno Desenvolvimento de Pesquisas Clínicas and Biolab Sanus Farmaceutica, the trial has completed recruitment. The study yielded foundational early-phase pharmacokinetic data to support its continued development in reproductive healthcare.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03443089	Completed	Contraception	Galeno Desenvolvimento de Pesquisas Clínicas\|Biolab Sanus Farmaceutica	2017-03-31	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Estradiol cypionate functions as an ester prodrug that releases estradiol to bind nuclear estrogen receptors, thereby inhibiting endothelin-1 synthesis and altering gonadotropin secretion within target tissues. This signaling modulation leads to the suppression of pituitary luteinizing hormone release and inhibition of ovulation, providing the physiological basis for its therapeutic use in contraception.

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>).