Menotropin Clinical Trials

Size	Price	Qty
5mg	USD 170

Clinical Trials

A completed clinical trial sponsored by Ferring Pharmaceuticals evaluated highly purified menotropin during ovarian stimulation in patients with female infertility. Although no specific clinical phase was reported, the study assessed cumulative live birth rates as a primary outcome for this follicle-stimulating therapy. Overall, this research highlights the therapeutic role of menotropin in strategies for female fertility management.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04876300	Completed	Infertility Female	Ferring Pharmaceuticals	2021-11-04	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Menotropin binds directly to follicle-stimulating hormone and luteinizing hormone receptors on ovarian target cells, activating downstream cyclic adenosine monophosphate-dependent signaling pathways to stimulate follicular growth and steroidogenesis. This targeted maturation of ovarian follicles promotes oocyte development, providing the biological driver required to overcome female infertility in clinical reproductive protocols.

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>).