Norelgestromin
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Norelgestromin: From Contraception (Transdermal Patch) to Amenorrhea
One-Sentence Summary
Norelgestromin is a progestin used in a combined transdermal contraceptive patch with ethinyl estradiol (marketed in South Africa as Evra). The TxGNN model predicts it may be relevant to amenorrhea, but there are currently 0 clinical trials and 0 publications supporting this direction, so the prediction rests on the model alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the SAHPRA registration record; the product is a contraceptive patch (background knowledge, not from the supplied data) |
| Predicted New Indication | Amenorrhea |
| TxGNN Prediction Score | 99.51% |
| Evidence Level | L5 (model prediction only) |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known background information, norelgestromin is the active metabolite of norgestimate and is delivered in a combined transdermal patch with ethinyl estradiol. As a progestin, it acts on the endometrium and the hypothalamic-pituitary-ovarian axis. That gives a general, plausible link to menstrual disorders, but this is background knowledge and not evidence from the supplied data.
The direction of effect is unclear. Progestin-containing products can cause amenorrhea or reduced bleeding, so the model may be picking up a drug-induced association rather than a therapeutic one. Progestins used to treat secondary amenorrhea (for example, a withdrawal challenge) are typically oral or injectable, not a transdermal combination patch. Whether the patch would suit this use has not been assessed.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
South Africa Market Information
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Reg. No. 36/18.7/0491 | Evra | Patch | Not recorded in the supplied data |
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is high, but there are no trials or publications behind it and no mechanism data. The prediction may also reflect a side effect of progestins rather than a treatment benefit.
To proceed, the following is needed:
- The SAHPRA package insert (warnings, contraindications, approved indication), which is required before any safety screening
- Mechanism of action data, for example from DrugBank
- A targeted literature and trial search to clarify whether the amenorrhea link is therapeutic or an adverse effect
- An assessment of whether a transdermal combination patch is a suitable route for this use
- Confirmation of Essential Medicines List (EML) status, if relevant
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any clinical use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.