Levonorgestrel
| Evidence Level: L2 | Predicted Indications: 5 |
Table of Contents
Levonorgestrel: Acne (disease)
One-Sentence Summary
Levonorgestrel is a progestin used in hormonal contraception, including emergency pills and intrauterine systems. The TxGNN model predicts it may be effective for acne (disease), and the evidence is rated L2: one randomized, placebo-controlled trial tested an oral contraceptive containing levonorgestrel with ethinyl estradiol in moderate acne. No clinical trials are registered for this prediction, and the 20 publications retrieved are mostly general reviews.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Acne (disease) |
| TxGNN Prediction Score | 0.9988 |
| Evidence Level | L2 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available for this drug. Based on known information, levonorgestrel is a progestin derived from 19-nortestosterone. It acts on progesterone receptors and has some residual androgenic activity, which in theory is unfavorable for acne.
Acne is driven in part by androgen action on the oil glands of the skin. Combined oral contraceptives that contain ethinyl estradiol raise sex hormone-binding globulin and lower free androgens, which can improve acne. A randomized, placebo-controlled trial of an oral contraceptive with 20 µg ethinyl estradiol and 100 µg levonorgestrel was done in moderate acne (PMID 12196750). That is the basis for the L2 rating.
This benefit comes from the combination with estrogen and should not be assumed for levonorgestrel on its own. The other literature gives only class-level context. Newer antiandrogenic progestins have documented skin benefits, and reviews describe the androgenic profile of progestins. A score of 0.9988 is a computational prediction, not clinical evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 12196750 | 2002 | RCT | Journal of the American Academy of Dermatology | Randomized, placebo-controlled trial of a low-dose oral contraceptive (ethinyl estradiol 20 µg + levonorgestrel 100 µg) for moderate acne |
| 15025547 | 2004 | Review | Drugs | Ethinylestradiol/chlormadinone acetate was significantly more effective than ethinylestradiol/levonorgestrel 0.03/0.15 mg in mild-to-moderate papulopustular acne |
| 21895044 | 2011 | Review | American Journal of Clinical Dermatology | Dermatological benefits of an estrogen/antiandrogenic progestin combination in acne, hirsutism, seborrhea and hair loss |
| 7825629 | 1995 | Review | The American Journal of Medicine | Androgenicity of progestins: 19-carbon progestins used in most contraceptives retain some androgenic activity |
| 30088446 | 2018 | Review | Current Drug Targets | Steroid interactions that contribute to sebum production and acne |
| 11727177 | 2001 | Review | Seminars in Reproductive Medicine | Levonorgestrel-releasing intrauterine system: contraception and reduced menstrual bleeding (indirect context) |
| 11091988 | 2000 | Review | Obstetrics and Gynecology Clinics of North America | Implantable contraception, including levonorgestrel implants (indirect context) |
| 8489751 | 1993 | Review | Annals of Medicine | Hormonal intrauterine devices releasing levonorgestrel (indirect context) |
India Market Information
The data compiled for this report list 20 valid single-ingredient registrations, and the list may be partial. The main ones are below.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Registration No. 134050 | Mirena Intrauterine Delivery System | packet of 1 Unit | Not available |
| Registration No. 74055 | Eloira Hormonal Intrauterine system | box of 1 Intrauterine system | Not available |
| Registration No. 86115 | Freedom 28 Tablet | strip of 28 tablets | Not available |
| Registration No. 108804 | Idoz 1.5mg Tablet | strip of 1 Tablet | Not available |
| Registration No. 175668 | Pronta 72 Emergency Contraceptive Tablet | strip of 1 Tablet | Not available |
Safety Considerations
- Drug Interactions: 162 interactions are recorded. The ones listed are of moderate level and include acarbose, aprepitant, canagliflozin, clotrimazole, dapagliflozin, ertugliflozin, exenatide, liraglutide, linagliptin, nateglinide and several insulin products. Many of these are glucose-lowering drugs.
Package insert warnings and contraindications were not available. Please refer to the package insert for them.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: One randomized, placebo-controlled trial supports an oral contraceptive containing levonorgestrel and ethinyl estradiol in moderate acne (evidence level L2). That benefit is likely tied to the estrogen combination, and levonorgestrel’s residual androgenic activity argues against benefit as a single agent. The high TxGNN score (0.9988) is a model prediction only.
To proceed, the following is needed:
- Package insert warnings and contraindications for the Indian products
- Mechanism of action data
- Confirmation of whether any benefit is specific to the combination with ethinyl estradiol or applies to levonorgestrel-containing products more broadly
- Review of the drug interaction profile, especially with glucose-lowering drugs, and of the patient groups where hormonal therapy is a concern
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.