Clinical Trials

Medroxyprogesterone is under evaluation in multiple investigator- and hospital-sponsored clinical trials that are currently in the not yet recruiting status. Led by institutions such as Jewish General Hospital and University Children's Hospital Zurich, these studies include a Phase 4 trial and an evaluation with a phase designation listed as not applicable. Research efforts target cardiovascular outcomes, specifically left and right ventricular dysfunction alongside quality of recovery, as well as pediatric respiratory infections including community-acquired pneumonia and Mycoplasma pneumoniae pneumonia.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05188222 Not yet recruiting
Left Ventricular Dysfunction|Quality of Recovery|Right Ventricular Dysfunction
Jewish General Hospital
2024-09-01 Phase 4
NCT06325293 Not yet recruiting
Community Acquired Pneumonia in Children|Mycoplasma Pneumoniae|Mycoplasma Pneumoniae Pneumonia
Christoph Berger|University Children''s Hospital Zurich
2024-07-01 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Medroxyprogesterone selectively binds to and activates the nuclear progesterone receptor, triggering conformational changes that modulate target gene transcription and downstream steroid-responsive signaling cascades. This receptor-mediated transcriptional control alters hormone-responsive tissue function, providing clinical relevance in modulating signaling pathways relevant to cardiac performance in ventricular dysfunction and inflammatory respiratory pathologies.

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>).

Note: Technical data last updated: Sep 1, 2026.