Ethinyl Estradiol Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Multiple clinical trials evaluate ethinyl estradiol, primarily focusing on contraception, pregnancy prevention, pharmacogenomic drug interactions, and pharmacokinetic profiles in healthy, overweight, or obese participants. Spanning Phase 1, Phase 2, and Phase 4, these studies range in status from recruiting to completed or terminated, with specific focus on drug-drug interactions and contraceptive vaginal rings. Trials are sponsored by pharmaceutical companies and academic institutions, including Incyte, Eli Lilly, Pfizer, Lupin Research, and Yale University in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06380205	Recruiting	Healthy Participants	Incyte Corporation	2024-05-07	Phase 1
NCT06334315	Not yet recruiting	Contraception\|Pharmacogenomic Drug Interaction	Yale University\|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	2024-05	Phase 4
NCT06039826	Active not recruiting	Overweight	Eli Lilly and Company	2023-09-12	Phase 1
NCT05671653	Terminated	Obesity	Pfizer	2023-01-19	Phase 1
NCT05360550	Completed	Pregnancy Prevention	Lupin Research Inc	2022-07-05	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ethinyl estradiol selectively binds to and activates nuclear estrogen receptors, triggering downstream receptor dimerization and altered gene transcription that suppresses pituitary secretion of luteinizing hormone and follicle-stimulating hormone, thereby preventing ovulation. This inhibition of gonadotropin release and suppression of follicular maturation underlie its primary clinical utility in contraception and pregnancy prevention, as investigated across Phase 1 through Phase 4 clinical trials.

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>).