Progesterone
| Evidence Level: L4 | Predicted Indications: 6 |
Table of Contents
Progesterone: Breast fibrocystic disease
One-Sentence Summary
Progesterone is a natural female sex hormone (a progestogen) that is already marketed in India in many oral and injectable products. The TxGNN model predicts it may be useful for breast fibrocystic disease. The support is indirect: no clinical trials are registered and the 19 publications are mostly older reviews and pathophysiology studies.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Breast fibrocystic disease |
| TxGNN Prediction Score | 0.9998 |
| Evidence Level | L4 |
| 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 currently available. Progesterone acts as a natural progestogen, and its role in balancing estrogen’s effect on breast tissue is the basis for the prediction.
Fibrocystic breast changes are the most common benign breast condition. Pathophysiology studies link them to an altered estradiol-to-progesterone (E2/P) ratio. One review describes “estrogen predominance and progesterone deficiency”, and a study of women with the condition examined the luteal-phase E2/P ratio. This gives a plausible reason to test progesterone supplementation.
The evidence is indirect, and I found no study that tested progesterone as a treatment for this condition. Progestogen effects on breast tissue are mixed, and some reviews raise safety concerns. The prediction is therefore best treated as a research question, not a treatment option.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 3511705 | 1986 | Review | Am J Obstet Gynecol | Describes the condition as driven by estrogen predominance and progesterone deficiency. Covers clinical picture and management. |
| 31168213 | 2018 | Observational | Acta Clin Croat | Compared the late-luteal estradiol/progesterone relationship in 50 women with the condition and 40 without. |
| 41438397 | 2025 | Cross-sectional | Int J Reprod Biomed | Examined the association between the condition and polycystic ovary syndrome phenotypes. |
| 28598826 | 2017 | RCT | Breast Dis | Double-blind placebo-controlled trial of metformin, not progesterone, for fibrocystic changes. Notes that the condition reflects proliferation in response to monthly estrogen and progesterone changes. |
| 34537861 | 2022 | Review | Virchows Arch | Reviews apocrine lesions of the breast, including benign cysts and adenosis. |
| 1936311 | 1991 | Review | Fertil Steril | Earlier oral contraceptives appeared to protect against benign breast disease. It is unclear whether current low-dose progestogen products do the same. |
| 6481706 | 1984 | Review | J Reprod Med | Reviews estrogen and progesterone effects on breast disease and concludes oral contraceptives may be slightly protective. |
| 3902125 | 1985 | Review | Breast Cancer Res Treat | Epidemiology and endocrinology of benign breast disease. |
| 7788004 | 1995 | Observational | Eur J Endocrinol | Measured thyroid hormones in serum and breast cyst fluid of women with the condition. |
| 22103710 | 2012 | Observational | Gynecol Endocrinol | Compared fibrocystic disease rates across PCOS phenotypes in 132 women, with hormonal and metabolic parameters. |
India Market Information
Progesterone is marketed in India. All 20 licence records in the data compiled for this report are valid, and the list may be partial. The licence records do not include approved indication text. The table shows five of them.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 95693 | Gestmate 200mg Capsule | Strip of 10 capsules | Not stated in the records |
| 100412 | Gestwel 200 Soft Gelatin Capsule | Strip of 10 soft gelatin capsules | Not stated in the records |
| 198621 | Rimgest 100 Injection | Ampoule of 2 ml injection | Not stated in the records |
| 72493 | Endogest 300 SR Tablet (Cipla) | Strip of 10 SR tablets | Not stated in the records |
| 182704 | Preservgest 200 Soft Gelatin Capsule (Abbott) | Strip of 15 soft gelatin capsules | Not stated in the records |
Safety Considerations
- Drug Interactions: 163 interactions are recorded. The ones listed here are all rated Moderate.
- Antidiabetic drugs: acarbose, albiglutide, alogliptin, metformin, pioglitazone, canagliflozin, chlorpropamide, dapagliflozin, saxagliptin, dulaglutide, empagliflozin, glimepiride, repaglinide, semaglutide, liraglutide and several insulins.
- Other drugs: aprepitant and clarithromycin.
Please refer to the package insert for other safety information, including warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is high (0.9998), and the E2/P imbalance gives a plausible rationale. But no clinical trials exist, the literature is mostly old reviews and pathophysiology studies, and none of the 19 publications tests progesterone as a treatment for this condition. Progestogen effects on breast tissue are mixed and raise safety concerns.
To proceed, the following is needed:
- Mechanism of action data
- A well-designed trial or a systematic review of progestogen therapy for fibrocystic breast changes
- A breast-safety assessment, including long-term risk
- Package insert warnings and contraindications for the marketed products
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.