Multiple clinical trials evaluate the therapeutic and pharmacokinetic profiles of megestrol across Phase I, Phase II, and non-phased designs. Sponsored by academic research institutions and pharmaceutical entities, these studies investigate indications including endometrial cancer, appetite stimulation in malnourished pediatric cancer patients, chronic obstructive pulmonary disease, and healthy volunteer pharmacokinetics. Exhibiting varied recruitment statuses—including completed and terminated protocols—these evaluations demonstrate the broad application of megestrol across oncological, respiratory, and nutritional management.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05332483 | Terminated | Endometrial Cancer |
Sunnybrook Health Sciences Centre|Ontario Institute for Cancer Research |
2022-07-05 | Phase 1 |
| NCT01589562 | Completed | Healthy |
Daewon Pharmaceutical Co. Ltd.|Asan Medical Center |
2012-04 | Phase 1 |
| NCT00439101 | Completed | Malnourished Children With Cancer |
University of British Columbia|University of Alberta |
2007-04 | Not Applicable |
| NCT00507949 | Completed | Chronic Obstructive Pulmonary Disease |
Rottapharm Spain |
2006-10 | Phase 2 |
(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>).