Hydroxyprogesterone Caproate
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
- Hydroxyprogesterone Caproate
- Hydroxyprogesterone Caproate: From an Injectable Progestin to Endometriosis of Uterus
Hydroxyprogesterone Caproate: From an Injectable Progestin to Endometriosis of Uterus
One-Sentence Summary
Hydroxyprogesterone caproate is a marketed injectable progestin (hormone) product in the United States. The TxGNN model predicts it may be effective for endometriosis of uterus, but there are 0 clinical trials and only 2 loosely related publications, so the evidence is weak.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Endometriosis of uterus |
| TxGNN Prediction Score | 99.98% |
| Evidence Level | L4 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 1 (ANDA211142) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, hydroxyprogesterone caproate is a progestin, and the pack’s own rationale notes that progestins are used clinically to suppress endometriosis. Mechanistically, it may be applicable to endometriosis of the uterus.
The plausibility rests on this class-level link only. Neither of the two retrieved papers tests hydroxyprogesterone caproate in endometriosis. One is a case report of spontaneous hemoperitoneum in pregnancy, in which endometriosis was a risk factor. The other is a 1985 histology study of uterine changes after sex hormone treatment. The very high model score is therefore not backed by clinical data.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 37488914 | 2023 | Case report | The American Journal of Case Reports | A 41-year-old woman with adenomyosis developed hemoperitoneum due to endometriosis at 28 weeks of pregnancy. It shows endometriosis as a risk factor for spontaneous hemoperitoneum in pregnancy and does not test this drug. |
| 3158227 | 1985 | Histopathology study | Akusherstvo i Ginekologiia | Structural characteristics of the pathologically changed uterus after sex hormone treatment. No abstract is available, and the link to this drug is indirect. |
US Market Information
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA211142 | Hydroxyprogesterone Caproate | Injection | AuroMedics Pharma LLC |
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: No clinical trial exists for this indication, and the two publications are only indirectly relevant (a pregnancy case report and a 1985 histology study). The prediction rests on the general progestin–endometriosis association, so it is not yet actionable.
To proceed, the following is needed:
- FDA package insert warnings and contraindications. This is a blocking gap for safety screening.
- Mechanism of action data (MOA), for example from DrugBank.
- Direct clinical evidence of hydroxyprogesterone caproate in endometriosis, such as trials or controlled studies.
- Review of the other predictions in this pack. Endometrial cancer (rank 8) and uterine corpus cancer (rank 6) have much more literature, at L3 and rated “Research Question”, including a 2000 Cochrane review of progestagens. They should be merged and assessed separately, since they are essentially the same disease.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.