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)
Mechanism and Biochemical Profile
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>).
- Medroxyprogesterone Solubility in DMSO
- Medroxyprogesterone Stock Solution
- Medroxyprogesterone Storage
- Medroxyprogesterone Stability
- Medroxyprogesterone Molecular Weight
- Medroxyprogesterone SMILES
- Medroxyprogesterone CAS Number
- Medroxyprogesterone Chemical Structure (2D and 3D)
- Medroxyprogesterone SDS|MSDS