Dienogest
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Dienogest: From Endometriosis to Amenorrhea
One-Sentence Summary
Dienogest is a selective progestin marketed in India as a 2 mg oral product; its approved indication text is not available in the data compiled for this report, although the literature points to endometriosis-related use. The TxGNN model predicts it may be effective for amenorrhea, but no clinical trials and only 7 loosely related publications are available. These publications describe amenorrhea mainly as a treatment effect rather than a therapeutic target. This is a model-driven research question, not an established repurposing opportunity.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the licence data (literature points to endometriosis) |
| Predicted New Indication | Amenorrhea |
| TxGNN Prediction Score | 0.9971 |
| Evidence Level | L5 |
| 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 | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available in the data compiled for this report. Based on known information, dienogest is a fourth-generation progestin with selective progesterone activity, antiproliferative and endometrium-decidualizing effects, and mild antigonadotropic action. It partially suppresses ovulation.
The link to amenorrhea is largely a pharmacological effect. Endometriosis treatment often aims to induce amenorrhea and a hypoestrogenic environment. The high TxGNN score probably reflects this association with menstrual-pattern changes rather than a therapeutic indication. Using dienogest in secondary amenorrhea, for example as a progestin challenge or for endometrial protection in hypoestrogenic states, is plausible. However, none of the supplied evidence directly supports it.
Other top-ranked predictions are weaker. These include primary ovarian failure, isolated growth hormone deficiency, hypogonadotropic hypogonadism, fragile X carrier symptoms, BPES variants and chromosomal disorders. They have no trials or literature and are likely network-proximity artifacts. Breast fibrocystic disease (score 0.9960) has one indirect publication on breast effects and is a more plausible secondary research question.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 39090694 | 2024 | Systematic review / Bayesian meta-analysis | BMC Pharmacol Toxicol | Summarizes adverse events of dienogest in endometriosis and adenomyosis, including bleeding-pattern changes |
| 29161960 | 2018 | Retrospective cohort (514 women) | Reprod Sci | Long-term (>12 months) dienogest 2 mg was effective and safe in ovarian endometrioma |
| 34405378 | 2022 | Review | Rev Endocr Metab Disord | Endocrine background of hormonal treatments for endometriosis |
| 41329046 | 2026 | Clinical/pharmacodynamic study | Eur J Contracept Reprod Health Care | Further evidence for 2 mg dienogest in endometriosis (inhibition ratio, transformation index) |
| 40543564 | 2025 | Review / imaging | J Pediatr Adolesc Gynecol | Advanced visualization for Müllerian anomalies; only indirectly relevant |
| 34918698 | 2021 | Case report | Medicine | Ovarian granulosa cell tumor in a patient with PCOS; unrelated context |
| 42438810 | 2026 | Case report | JCEM Case Rep | Primary hyperparathyroidism unmasked after dienogest-altered estrogen dynamics (adverse effect) |
For the secondary candidate, breast fibrocystic disease, one publication is available: 19499407 (2009, Gynecol Endocrinol). In a pilot study of 21 women with endometriosis given high-dose dienogest, breast ultrasound showed a significant reduction in mammary gland size and regression of mastopathic changes.
India Market Information
Twenty valid single-ingredient licences are registered. The approved indication text is not provided for any of them. Five representative authorizations:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 68916 | Dienoziv 2 Tablet (Salveo Lifecare) | Strip of 10 tablets | Not specified |
| 58753 | Dinofirst Tablet (Akumentis Healthcare Ltd) | Strip of 14 tablets | Not specified |
| 34961 | Cipgest 2mg Tablet (Cipla Ltd) | Strip of 10 tablets | Not specified |
| 215772 | Terozesta 2mg Tablet (Mankind Pharma Ltd) | Strip of 10 tablets | Not specified |
| 112503 | Ibinest Soft Gelatin Capsule (Indiabulls Pharmaceutical Ltd) | Strip of 10 soft gelatin capsules | Not specified |
All products are oral.
Safety Considerations
Contraindication signals from the knowledge graph (these are model-derived associations, not label text): hypertension, epilepsy, anxiety and neurotic disorders, porphyria, kidney disease, liver disease, gallbladder disease, hypothyroidism, systemic lupus erythematosus, asthma, diabetes mellitus and diabetic ketoacidosis, hypertriglyceridemia, hypercalcemia and related calcium or phosphorus disorders, female breast carcinoma, and thrombophlebitis.
Drug Interactions: 37 interactions were identified. Major-level interactions in the listed subset include:
- Sugammadex
- Griseofulvin
- Bexarotene
- Brigatinib
- Dabrafenib
- Encorafenib
Moderate-level examples include linaclotide, metreleptin, prucalopride, miltefosine, adalimumab, anakinra, cladribine and enasidenib. Ethanol is a minor interaction.
Case-report signal: One report describes primary hyperparathyroidism unmasked after dienogest-altered estrogen dynamics, which is relevant to calcium homeostasis.
Please refer to the package insert for label warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The amenorrhea prediction has a high model score, but no clinical trials support it. The literature treats amenorrhea as an expected effect of dienogest rather than a condition it treats, so the evidence is only L4. The other top predictions have no evidence at all.
To proceed, the following is needed:
- Package insert warnings and contraindications from the India regulator (a blocking gap for safety screening)
- Approved indication text for the registered products, to confirm the original indication
- Detailed mechanism-of-action data from DrugBank
- A clear definition of the intended use (for example secondary amenorrhea or progestin challenge), followed by a targeted literature search and trial design
- Further assessment of breast fibrocystic disease as a secondary research question, supported by controlled data
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.