Dydrogesterone
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Dydrogesterone
- Dydrogesterone: From Hormonal Gynaecological Use to Seborrheic Keratosis (Top-Ranked TxGNN Prediction)
Dydrogesterone: From Hormonal Gynaecological Use to Seborrheic Keratosis (Top-Ranked TxGNN Prediction)
One-Sentence Summary
Dydrogesterone is a synthetic progestogen that acts on the progesterone receptor and is used for irregular menstrual cycles and for preventing miscarriage in at-risk patients. The TxGNN model ranks seborrheic keratosis as its top prediction, but there are no clinical trials and no publications supporting it, so this is a model prediction only. The best-supported candidate among the ten predictions is amenorrhea, which has 5 publications (indirect or case-level) and no clinical trials.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the Singapore licence records. The pharmacology data describe use for irregular menstrual cycles and prevention of miscarriage in at-risk patients. |
| Predicted New Indication | Seborrheic keratosis (rank 1); amenorrhea is the best-supported alternative (rank 9) |
| TxGNN Prediction Score | 92.06% (seborrheic keratosis); 88.53% (amenorrhea) |
| Evidence Level | L5 (seborrheic keratosis); L4 (amenorrhea) |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 2 |
| Recommended Decision | Hold (seborrheic keratosis); amenorrhea is a research question |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data are not available. Based on the pharmacology data compiled for this report, dydrogesterone is a synthetic progestogen that targets the progesterone receptor (PGR), and it is used for menstrual-cycle disorders and for supporting pregnancy in women at risk of miscarriage.
Seborrheic keratosis (rank 1). No plausible mechanistic link between progesterone receptor agonism and seborrheic keratosis is established in the available data. The high score (0.92) is a computational output and not evidence of benefit.
Other top-ranked predictions. Ranks 2 to 8 are largely haematological conditions: myelodysplastic syndrome and related entities (including refractory cytopenia of childhood, unclassified MDS, and the 5q deletion), aregenerative anaemia, and a congenital sideroblastic anaemia. They form one cluster of related predictions, so they are not independent evidence. Rank 3 is vulvar inverted follicular keratosis. None has any supporting trial or publication, and a hormonal effect on blood-cell production is speculative here.
Amenorrhea (rank 9). This is the only prediction with a biologically plausible link. Progestogen or estroprogestagen therapy is used to induce withdrawal bleeding and support endometrial development in amenorrhea, premature ovarian insufficiency, and Turner syndrome. It is also close to dydrogesterone's existing use in menstrual disorders, so it may be an extension of the current indication rather than a true repurposing.
Cholecystolithiasis (rank 10). Progestogens are generally associated with increased gallstone risk, so a therapeutic benefit is not supported and a safety concern is possible.
Clinical Trial Evidence
Currently no related clinical trials registered for any of the ten predicted indications.
Literature Evidence
Only the amenorrhea prediction has publications (5 records). Study designs could not be confirmed from the data, and dydrogesterone-specific efficacy is not verified from the supplied titles.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 36200708 | 2022 | Systematic review (Cochrane) | Cochrane Database of Systematic Reviews | Hormone therapy for uterine and endometrial development in women with premature ovarian insufficiency, a condition marked by amenorrhoea and low oestrogen |
| 23185193 | 2012 | Cohort / genetic association | Archives of Medical Science | Long-term effects of estroprogestagen therapy on bone mineral density in girls with functional hypothalamic amenorrhea, by oestrogen receptor-α genotype |
| 556711 | 1977 | Review | Fortschritte der Medizin | Review of gestagen therapy in reproduction; dydrogesterone is mentioned as a "more gentle" option for endometriosis in women wanting further children |
| 34219314 | 2021 | Case report | J Obstet Gynaecol Res | Luteal phase deficiency in early pregnancy in a woman with hypopituitarism after craniopharyngioma resection, who had received sequential oestrogen and progesterone for primary amenorrhea |
| 39901965 | 2025 | Case report | SAGE Open Med Case Rep | Turner syndrome diagnosed in a 44-year-old woman presenting with ischemic cardiomyopathy and primary amenorrhea |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN11255P | DUPHASTON TABLET 10 mg (Film-coated) | Film-coated tablet | Not stated in the licence record |
| SIN12121P | FEMOSTON CONTI 1/5 TABLET | Film-coated tablet | Not stated in the licence record |
Both licences are valid single-ingredient registrations held by Abbott Biologicals B.V. Both products are oral film-coated tablets.
Safety Considerations
- Drug Interactions: Only one pharmacology entry was found. It describes dydrogesterone's action on the progesterone receptor (PGR) and does not describe an interaction with another drug.
For warnings and contraindications, please refer to the package insert.
Conclusion and Next Steps
Decision: Hold
Rationale: The top-ranked prediction, seborrheic keratosis, rests on a model score alone, with no trials, no literature, and no plausible mechanism. The same is true of the haematological cluster (ranks 2 to 8) and of cholecystolithiasis, where a safety concern is possible. Amenorrhea (L4) is worth a focused research question, but its evidence is indirect and sits close to the existing indication.
To proceed, the following is needed:
- The package insert, to confirm approved indications, warnings, and contraindications (a blocking gap for safety screening)
- Mechanism-of-action data from DrugBank
- For amenorrhea: a targeted literature review to confirm dydrogesterone-specific efficacy and study designs
- For seborrheic keratosis and the haematological predictions: any mechanistic or clinical rationale before further consideration
- A gallstone-risk safety assessment if cholecystolithiasis is to be considered further
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.