Carboprost Clinical Trials

Size	Price	Qty
1mg	USD 97

Clinical Trials

Multiple academic-sponsored clinical trials evaluate carboprost for gynecologic and obstetric applications across early exploratory and post-marketing phases. An active, recruiting Early Phase 1 trial sponsored by Northwestern University investigates carboprost tromethamine during the surgical resection of uterine fibroids and leiomyomas. Additionally, a completed Phase 4 study at the University of Iowa assessed prophylactic carboprost-containing regimens to prevent uterine atony with hemorrhage in patients undergoing non-elective cesarean sections.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05518812	Recruiting	Fibroid Uterus\|Gynecologic Disease\|Leiomyoma Uterine	Northwestern University	2022-07-12	Early Phase 1
NCT03904446	Completed	Uterine Atony With Hemorrhage	Cynthia Wong\|University of Iowa	2019-06-08	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Carboprost selectively binds to and activates the prostaglandin F2α receptor, triggering intracellular calcium mobilization within myometrial cells. This activation induces potent, rhythmic contractions of uterine smooth muscle tissue and localized vascular constriction, providing oxytocic efficacy relevant for controlling uterine atony with hemorrhage and assisting in the surgical management of uterine leiomyomas.

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>).