Lynestrenol
| Evidence Level: L3 | Predicted Indications: 4 |
Table of Contents
- Lynestrenol
- Pharmacist Assessment Report
- Lynestrenol: From an Unspecified Original Indication to Migraine Disorder
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Lynestrenol: From an Unspecified Original Indication to Migraine Disorder
One-Sentence Summary
Lynestrenol is an oral progestin. The licence records compiled for this report do not state an approved indication. The TxGNN model predicts it may be useful for migraine disorder. Support is thin: no clinical trials and 2 publications, one a 1963 clinical report and the other a 2026 review of combined oral contraceptive substances.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the licence records |
| Predicted New Indication | Migraine disorder |
| TxGNN Prediction Score | 0.9949 |
| Evidence Level | L3 (see note below) |
| India Market Status | Listed in a compiled Indian medicine price dataset (2 of 2) – CDSCO approval status is not included in this data |
| Number of Listed Products | 2 (valid: 2) |
| Recommended Decision | Hold |
Evidence level note: Both publications directly address migraine. However, one is a general review and the other a 1963 report that appears to be uncontrolled and has no abstract. Neither is a controlled trial, so L3 is the most the evidence can support.
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Lynestrenol is a progestin that is converted in the body to norethisterone. It suppresses ovulation and helps stabilize hormonal fluctuations.
Menstrually related migraine is thought to be triggered by the fall in estrogen late in the luteal phase. Steadying hormone levels could therefore reduce this trigger. A 1963 Swedish report describes lynestrenol (Orgametril) as prophylactic treatment of migraine. A 2026 review also notes that some women with menstrual-cycle-related headaches may improve on hormonal contraception, particularly with the 28/0 regimen.
This evidence is indirect and old, and the TxGNN score is a computational prediction only. Combined oral contraceptives that contain estrogen are contraindicated in migraine with aura because of stroke risk. Any exploration should therefore favor progestin-only regimens.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 41723577 | 2026 | Review | Medical Science Monitor | Compares substances in combined oral contraceptives used for acne, hirsutism, migraine and dysmenorrhea. Notes that combined contraceptives are contraindicated in migraine with aura, but menstrual-cycle-related headaches may improve, especially with the 28/0 regimen. |
| 14091721 | 1963 | Clinical observation (likely uncontrolled) | Svenska Läkartidningen | Title describes prophylactic treatment of migraine with lynestrenol (Orgametril). No abstract is available, so results cannot be summarized. |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Registration No. 124300 | Lyscost Tablet | Strip of 28 tablets | Not stated in the licence record |
| Registration No. 141565 | Minikare Tablet | Strip of 28 tablets | Not stated in the licence record |
Safety Considerations
Please refer to the package insert for safety information.
One point from the literature is worth noting: estrogen-containing combined oral contraceptives are contraindicated in migraine with aura. No drug interaction records were found for lynestrenol.
Conclusion and Next Steps
Decision: Hold
Rationale: The only direct support for migraine is a 1963 report that appears uncontrolled and a general 2026 review. There are no registered trials. The licence records do not state an approved indication, and no package insert safety data is available. The prediction is a research question rather than something ready for development.
To proceed, the following is needed:
- Package insert warnings and contraindications from the India licence holders
- Mechanism of action data from DrugBank
- Retrieval of the full text of the 1963 report, and a search for controlled studies of progestin-only treatment in menstrually related migraine
- A safety assessment for women with migraine with aura, with a progestin-only approach considered
- If the evidence supports it, a well-designed controlled trial in menstrually related migraine
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.