Cyproterone Acetate
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
- Cyproterone Acetate
- Cyproterone Acetate: From Hormonal (Antiandrogen/Progestin) Therapy to Migraine Disorder
Cyproterone Acetate: From Hormonal (Antiandrogen/Progestin) Therapy to Migraine Disorder
One-Sentence Summary
Cyproterone acetate (CPA) is a progestin and antiandrogen, used in South Africa in combined tablet products. The TxGNN model predicts it may be effective for migraine disorder, but there are no registered clinical trials and only 3 loosely related publications, none testing CPA as a migraine treatment.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the SAHPRA records retrieved (indication text is blank for all 4 registrations) |
| Predicted New Indication | Migraine disorder |
| TxGNN Prediction Score | 99.66% |
| Evidence Level | L4 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 4 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the Evidence Pack. CPA is known as a progestin and antiandrogen, so its main pharmacology is hormonal.
Hormonal fluctuation, especially oestrogen withdrawal, is a recognised migraine trigger, so a hormonal link is plausible. A 2003 review reports that progestins interact with GABA-A receptors and dopamine and opioid systems. It also notes that CPA increases dopaminergic responses and binds opiate receptors independently of its classical effects. This is the only mechanistic clue in the evidence, and it is indirect.
No study has tested CPA as a migraine treatment. The TxGNN score comes from a knowledge-graph prediction only. The safety direction also needs care: migraine with aura is a recognised caution for combined hormonal contraceptives because of stroke risk.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 14670648 | 2003 | Review | Maturitas | Progestins act on GABA-A, dopamine and opioid systems; CPA increases dopaminergic responses and binds opiate receptors |
| 12390622 | 2002 | Cohort | Headache | Compares three oral hormone replacement schemes and their effect on migraine in postmenopausal women; not a CPA study |
| 10857213 | 2000 | Review | Zentralblatt fur Gynakologie | Long-term side effects of CPA-containing gynaecological therapy, including the debate on mutagenic potential; no migraine data |
None of these papers shows that CPA prevents or treats migraine.
South Africa Market Information
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Reg. No. 29/21.8.2/0685 | Minerva | Tablet | Not provided in retrieved record |
| Reg. No. 38/21.8.2/0248 | Adco-Fem 35 | Tablet | Not provided in retrieved record |
| Reg. No. 38/21.8.2/0055 | Diva-35 | Tablet | Not provided in retrieved record |
| Reg. No. 33/21.8.2/0185 | Ginette | Tablet | Not provided in retrieved record |
All products are oral tablets. Essential Medicines List status could not be determined from the data.
Safety Considerations
- Thromboembolic risk (from the literature retrieved for this drug): Studies of CPA/ethinyl estradiol contraceptives report increased venous thromboembolism risk, prothrombotic changes and higher thrombin generation. The risk is especially notable with factor V Leiden.
- Migraine with aura: This is a recognised caution for combined hormonal contraceptives because of stroke risk. In a migraine population, the safety signal points toward harm rather than benefit.
Please refer to the SAHPRA-approved Professional Information (PI) for full safety information. Report adverse drug reactions to SAHPRA.
Conclusion and Next Steps
Decision: Hold
Rationale: There are no trials and no CPA-specific migraine literature, so the prediction rests on the TxGNN score and an indirect hormonal rationale. The thrombosis and stroke-risk signals for CPA-containing combined products count against use in migraine, especially migraine with aura.
To proceed, the following is needed:
- SAHPRA package insert warnings and contraindications (blocking for safety screening)
- Mechanism of action data (for example from DrugBank)
- Any CPA-specific migraine study, or a formal benefit-risk review
- Note: among the other predictions in this pack, amenorrhoea has the strongest support (evidence level L3, including a Phase 4 study of ethinyl estradiol/CPA in menstrual irregularity of hyperandrogenic origin). It may be a better-supported direction to review first.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.