Hydroxyprogesterone Caproate
| 證據等級: L5 | 預測適應症: 10 個 |
目錄
- Hydroxyprogesterone Caproate
- Hydroxyprogesterone Caproate: From Progestin Hormone Therapy to Endometriosis
Hydroxyprogesterone Caproate: From Progestin Hormone Therapy to Endometriosis
One-Sentence Summary
Hydroxyprogesterone caproate (17-OHPC, DrugBank DB06789) is a synthetic progestin; its formally documented original indication is not available in this evidence pack (no Taiwan/TFDA license on file), though the source literature references its historical use in pregnancy maintenance and hormonal cancer therapy. The TxGNN model predicts it may be effective for endometriosis of uterus, with 0 clinical trials and only 2 publications currently supporting this specific direction — both tangential rather than direct efficacy evidence.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Endometriosis of uterus |
| TxGNN Prediction Score | 99.98% |
| Evidence Level | L4 (mechanism-only; no controlled clinical evidence) |
| US Market Status | Not marketed |
| Number of NDAs | 0 |
| Recommended Decision | Hold (Research Question stage) |
Original Indication is omitted from this table — no approved-indication text is available (drug not marketed in Taiwan; no TFDA license on file).
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available for this specific DrugBank entry (flagged as a High-severity data gap: DG002). Based on the drug’s known pharmacological class, hydroxyprogesterone caproate is a synthetic progestin (17α-hydroxyprogesterone 17-hexanoate), acting as a progesterone receptor agonist — this class identity is echoed throughout the evidence pack’s own rationale text for multiple candidate indications (e.g., “黃體素類藥物”, “17-OHPC 為合成黃體素”).
Progestins are an established class-level therapy for endometriosis: by activating the progesterone receptor, they suppress estrogen-dependent proliferation of ectopic endometrial tissue. This makes the mechanistic link for “endometriosis of uterus” biologically plausible as a class effect, not a drug-specific discovery.
However, the two supporting papers do not directly evidence this use: one is a 2023 case report of spontaneous hemoperitoneum in pregnancy in a patient with endometriosis/adenomyosis (context is 17-OHPC’s use in pregnancy maintenance, not treatment of endometriosis), and the other is a 1985 Russian pathology study on uterine structural changes after sex-hormone treatment, with no efficacy data. Neither constitutes direct evidence that this drug treats endometriosis.
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 | 41-year-old woman with adenomyosis/endometriosis developed spontaneous hemoperitoneum at 28 weeks’ gestation; discusses endometriosis as a risk factor for this pregnancy complication, not drug efficacy against endometriosis. |
| 3158227 | 1985 | Observational/Pathology study | Akusherstvo i ginekologiia | Russian-language study of structural (pathological) changes in the diseased uterus following sex-hormone treatment; abstract not available, no efficacy outcome reported. |
US Market Information
This drug is not marketed in Taiwan (0 licenses on file), so no authorization table is available.
Safety Considerations
Please refer to the package insert for safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The mechanistic rationale (progestin class effect on ectopic endometrial tissue) is plausible, but the two available publications are tangential — neither is a controlled or observational study evaluating this drug for endometriosis. With zero clinical trials and no TFDA safety data on file (Blocking gap DG001), the evidence does not yet support proceeding.
To proceed, the following is needed:
- TFDA label / package insert (warnings, contraindications) — currently blocking any safety review (DG001)
- Confirmed mechanism-of-action documentation for this DrugBank entry (DG002)
- Direct efficacy studies (clinical or preclinical) evaluating hydroxyprogesterone caproate specifically for endometriosis
- Note: within the same evidence pack, endometrial cancer and uterine corpus cancer (ranks 8 and 6) carry substantially stronger evidence — L3, “Proceed with Guardrails,” each with 8–20 literature citations including Cochrane systematic reviews — and may warrant separate, prioritized evaluation as repurposing candidates for this drug.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.