Dienogest
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Dienogest: From Endometriosis to Amenorrhoea
One-Sentence Summary
Dienogest is an oral progestin. The trials and literature in the Evidence Pack concern its use in endometriosis, and the SAHPRA record supplied does not state an approved indication. The TxGNN model predicts it may be effective for amenorrhoea, with 4 clinical trials and 6 retrieved publications. None of these studies treats amenorrhoea as the condition being treated, so this is best read as a research question, not a therapeutic claim.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the SAHPRA record supplied. The trials and literature concern endometriosis. |
| Predicted New Indication | Amenorrhoea |
| TxGNN Prediction Score | 99.71% |
| Evidence Level | L4 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Dienogest is a progestin with strong antiproliferative activity on the endometrium. It partially suppresses ovulation and induces endometrial atrophy, which plausibly links it to changes in menstrual pattern.
Amenorrhoea is a frequent effect of dienogest when it is used for endometriosis. The model’s prediction may therefore reflect an expected pharmacodynamic effect or adverse-effect signal, not a treatable indication. A 2026 pharmacodynamic paper notes that hormonal endometriosis treatments aim to induce amenorrhoea. This supports the mechanistic link but does not show that amenorrhoea is a condition dienogest should be used to treat.
The high TxGNN score is a model prediction only. It should not be treated as evidence of efficacy.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT07164183 | Phase 3 | Recruiting | 290 | Open-label randomised non-inferiority study of Indinol Forto 200 mg capsules vs Visanne (dienogest) 2 mg tablets in endometriosis. It has no results yet, and the amenorrhoea link is not confirmed. |
| NCT07204093 | N/A | Active, not recruiting | 138 | Compares progestin-based regimens (transdermal estradiol with dienogest vs drospirenone) for patient satisfaction in endometriosis. The link to amenorrhoea is indirect. |
| NCT04495855 | N/A | Completed | 968 | Real-world observational study of dienogest (Visanne) in endometriosis. Useful for safety and bleeding-pattern data, but does not target amenorrhoea. |
| NCT02425462 | N/A | Completed | 895 | Observational cohort of dienogest and quality of life in Asian women with endometriosis. Indirect support only. |
No SANCTR or PACTR registrations were identified in the data provided.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 39090694 | 2024 | Systematic review/Meta-analysis | BMC Pharmacol Toxicol | Summarises adverse events of dienogest and their prevalence during treatment for endometriosis and adenomyosis. |
| 34405378 | 2022 | Review | Rev Endocr Metab Disord | Endocrine background of hormonal treatments for endometriosis. |
| 29161960 | 2018 | Retrospective cohort | Reprod Sci | Long-term (beyond 12 months) efficacy, safety and recurrence of dienogest in 514 women with ovarian endometrioma. |
| 41329046 | 2026 | Pharmacodynamic study | Eur J Contracept Reprod Health Care | Reports a high inhibition ratio and transformation index for dienogest 2 mg, supporting its use in endometriosis. It notes that hormonal therapy aims to induce amenorrhoea. |
Two other retrieved items, on Müllerian anomaly imaging (PMID 40543564) and an ovarian granulosa cell tumour case report (PMID 34918698), have no clear bearing on dienogest and are not counted as evidence.
South Africa Market Information
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Reg. No. 43/18.8/0591 | Qlaira | Tablet (oral) | Not stated in the record supplied |
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
Conclusion and Next Steps
Decision: Hold
Rationale:
- The evidence is L4 (model prediction with mechanistic plausibility). No study treats amenorrhoea as a condition for dienogest, and the only Phase 3 trial is still recruiting and concerns endometriosis.
- The signal may simply reflect a known effect of dienogest. In addition, the SAHPRA package insert warnings and contraindications have not been obtained, which blocks safety screening.
To proceed, the following is needed:
- SAHPRA Professional Information (PI) for Qlaira, covering the approved indication, warnings and contraindications
- Mechanism of action data from DrugBank
- Full-record review of NCT07164183 to confirm its condition, comparator and endpoints
- A clinical rationale showing amenorrhoea is a meaningful treatment target and not an expected effect of therapy
The other nine predictions (ranks 2–10) are also on Hold. None has direct clinical evidence, and several, such as primary ovarian failure and hypogonadotropic hypogonadism, run against dienogest’s known gonadotropin-suppressing action.
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.