Hydroxyprogesterone caproate Clinical Trials

Size	Price	Qty
100mg	USD 147

Clinical Trials

A clinical trial investigating hydroxyprogesterone caproate for pregnancy-associated conditions has been completed. Sponsored by Lumara Health Inc., this multi-center Phase 1 study evaluated the pharmacokinetic properties of the agent and its active metabolites in pregnant women to establish critical pharmacological parameters. Overall, clinical research for this progestational agent remains concentrated on early-phase pharmacokinetic characterization in pregnancy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01899846	Completed	Pregnancy	Lumara Health Inc.	2013-07	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Hydroxyprogesterone caproate selectively binds to and activates nuclear progesterone receptors, triggering downstream alterations in transcriptional signaling that modify cervical mucus and suppress myometrial contractility. These physiological effects maintain uterine quiescence, providing a functional rationale for its clinical application in managing pregnancy.

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>).