Ethinylestradiol
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Ethinylestradiol: From Acne and Postmenopausal Conditions to Elevated Plasma Zinc
One-Sentence Summary
Ethinylestradiol is a synthetic estrogen, used mainly in combined oral contraceptives, and its knowledge-graph indications include acne, postmenopausal osteoporosis and postmenopausal atrophic vaginitis. The TxGNN model predicts it may be effective for elevated plasma zinc, but there are 0 clinical trials and 0 publications supporting this direction. The prediction is model-derived only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Acne, postmenopausal osteoporosis, osteoporosis, postmenopausal atrophic vaginitis (from the knowledge graph; no approved indication text is available in the New Zealand licence records) |
| Predicted New Indication | Zinc, elevated plasma |
| TxGNN Prediction Score | 99.63% |
| Evidence Level | L5 |
| New Zealand Market Status | Cancelled only (no currently valid licences) |
| Number of Authorizations | 7 (all cancelled) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available. Ethinylestradiol is a synthetic estrogen found in combined contraceptive products in New Zealand, such as those paired with norethisterone, levonorgestrel or desogestrel.
Estrogens are reported to influence circulating trace-element levels. For example, they can raise serum copper and ceruloplasmin and alter zinc distribution through changes in binding proteins such as albumin and alpha-2-macroglobulin. This is a plausible but unverified biological connection, and the direction of any effect on plasma zinc is uncertain.
Elevated plasma zinc is a laboratory finding rather than a typical treatment target, so no therapeutic rationale is evident. The high TxGNN score (rank 2283) should be treated as a model output only, not as evidence of benefit.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
New Zealand Market Information
All licences are cancelled, and no approved indication text is recorded for them.
| Authorization Number | Product Name | Dosage Form | Status |
|---|---|---|---|
| 303542 | Brevinor 1/28 | Tab 35 mcg with norethisterone 1 mg and 7 inert tab | Cancelled |
| 2636077 | Norimin | Tab 35 mcg with norethisterone 500 mcg and 7 inert tab | Cancelled |
| 410691 | Norimin | Tab 35 mcg with norethisterone 500 mcg and 7 inert tab | Cancelled |
| 2637138 | Oralcon 30 ED | Tab 30 mcg with levonorgestrel 150 mcg and 7 inert tablets | Cancelled |
| 682055 | Mercilon 28 | Tab 20 mcg with desogestrel 150 mcg and 7 inert tab | Cancelled |
Two further cancelled licences are not shown: Ginet (2455455) and Lo-Oralcon 20 ED (2637111).
Safety Considerations
- Contraindications (from the knowledge graph, not label text): hypertension and hypertensive disorders, epilepsy, anxiety and neurotic disorders, dysthymic disorder, porphyria (including inherited forms), kidney disease, liver disease, gallbladder disease, hyperglycaemia, diabetes mellitus and diabetic ketoacidosis, congestive heart failure, hypercalcaemia (including humoral hypercalcaemia of malignancy), adrenocortical insufficiency and Addison disease, hypothyroidism (including myxedema and congenital hypothyroidism), systemic lupus erythematosus, asthma (including intrinsic and allergic), benign prostatic hyperplasia, and pyoureter.
- Drug Interactions: 412 interactions were identified in total. The main ones listed are mostly Moderate.
- Antidiabetic agents: acarbose, acetohexamide, albiglutide, alogliptin, chlorpropamide, dulaglutide, empagliflozin, glimepiride, glipizide, glyburide.
- Corticosteroids: betamethasone, budesonide, dexamethasone.
- Antibiotics: doxycycline, amoxicillin, clarithromycin.
- Others: chenodeoxycholic acid, eliglustat.
- Minor interactions: ascorbic acid, cimetidine.
Please refer to the package insert for authoritative warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests only on a model score, with no clinical trials, no literature and no established mechanistic link. Elevated plasma zinc is a laboratory finding rather than a disease with a therapeutic target. In addition, all New Zealand licences for this drug are cancelled.
To proceed, the following is needed:
- Mechanism of action data for ethinylestradiol
- Package insert warnings and contraindications from Medsafe
- Evidence that elevated plasma zinc is a clinically meaningful treatment target, and that estrogens lower zinc levels
- A route and formulation compatibility assessment
- A safety review against the long list of knowledge-graph contraindications and drug interactions
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.