Norgestrel Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Several clinical trials evaluate norgestrel across early-stage Phase I and Phase II research, targeting indications including contraception, transdermal contraceptive efficacy, relapsing multiple sclerosis, and pharmacokinetic drug interactions in healthy female cohorts and disease populations. Supported by industry sponsors such as Viatris Inc., Boehringer Ingelheim, UCB Biopharma, and Merck KGaA, these studies encompass recruiting, completed, and terminated recruitment statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05896384	Recruiting	Healthy	Boehringer Ingelheim	2023-12-07	Phase 1
NCT06048536	Completed	Contraception	Viatris Inc.	2023-12-22	Phase 2
NCT04131517	Terminated	Healthy Female Participants	UCB Biopharma SRL\|UCB Pharma	2019-10-23	Phase 1
NCT03745144	Completed	Relapsing Multiple Sclerosis (RMS)	Merck KGaA Darmstadt Germany	2019-01-17	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Norgestrel selectively binds to progesterone receptors, leading to downstream suppression of hypothalamic gonadotropin-releasing hormone and reduced pituitary secretion of luteinizing hormone. This inhibitory cascade prevents the ovulatory surge and alters endometrial histology for oral contraception, while also mediating neuroprotective signaling cellularly relevant to neuroinflammatory conditions like relapsing multiple sclerosis.

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>).