Norethindrone Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Multiple clinical trials have evaluated norethindrone across early- to late-phase studies, investigating diverse indications such as contraception, simple ovarian cysts, pharmacokinetic interactions in healthy females, and recurrent bacterial vaginosis linked to HIV risk. Sponsored by academic institutions, biopharmaceutical firms, and research consortia, these registered trials are currently categorized as completed or of unknown recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05293574	Unknown status	Ovarian Cyst Simple	Assiut University	2022-10-01	Phase 4
NCT05294341	Completed	Contraception	Milton S. Hershey Medical Center	2022-07-22	Phase 4
NCT04016753	Completed	Healthy Participants	Bristol-Myers Squibb	2019-08-05	Phase 1
NCT02905890	Completed	Bacterial Vaginosis\|HIV	London School of Hygiene and Tropical Medicine\|Imperial College London\|University of Liverpool\|MRC/UVRI and LSHTM Uganda Research Unit	2017-10-02	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a synthetic progestin, norethindrone selectively binds to intracellular progesterone receptors, triggering signaling changes that inhibit hypothalamic gonadotropin-releasing hormone release and suppress the pre-ovulatory luteinizing hormone surge. This downregulates follicular maturation and prevents ovulation, providing the biological mechanism for its clinical evaluation in oral contraception, simple ovarian cyst management, and related gynecological conditions.

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>).