Clinical Trials
Several clinical trials evaluate dydrogesterone across various gynecological and reproductive conditions, including early pregnancy bleeding, recurrent pregnancy loss, endometriosis, sexual dysfunction, and irregular menstrual cycles. Encompassing Phase 2 and 3 trials alongside observational and non-applicable phase protocols, these studies are supported by academic medical institutions and industry sponsors such as Abbott and Fudan University. Across these records, recruitment statuses vary to include completed, terminated, and unknown trial statuses.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05186779 | Terminated | Early Pregnancy Bleeding|Recurrent Pregnancy Loss |
Center for Epidemiology and Health Research Germany|Abbott Products Operations AG |
2021-12-15 | -- |
| NCT04287205 | Completed | Endometriosis|Sexual Dysfunction |
Kanuni Sultan Suleyman Training and Research Hospital |
2019-04-20 | Not Applicable |
| NCT02706470 | Unknown status | Miscarriage Recurrent |
Fudan University |
2016-05 | Phase 2|Phase 3 |
| NCT01711216 | Completed | Irregular Menstrual Cycle |
Abbott |
2012-08 | -- |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Compliance for Clinical Use
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>).