Goserelin
| Evidence Level: L3 | Predicted Indications: 3 |
Table of Contents
Goserelin: From Endometriosis to amenorrhea
One-Sentence Summary
Goserelin is a GnRH (gonadotropin-releasing hormone) agonist, originally used to treat endometriosis. The TxGNN model predicts it may be effective for amenorrhea, but this is largely an expected pharmacological effect of ovarian suppression rather than a distinct therapeutic indication. The data compiled for this report include 1 clinical trial (of low relevance) and 15 publications, mostly in breast cancer and endometriosis settings.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Endometriosis (the data compiled for this report show no approved-indication text in the India licences) |
| Predicted New Indication | Amenorrhea |
| TxGNN Prediction Score | 0.9999 |
| Evidence Level | L3 |
| India Market Status | Listed in a compiled Indian medicine price dataset (3 of 3) – CDSCO approval status is not included in this data |
| Number of Listed Products | 3 (valid: 3) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not formally available in the data compiled for this report. Based on known pharmacology, goserelin is a GnRH agonist. Continuous administration desensitises pituitary GnRH receptors, which suppresses LH and FSH and lowers ovarian estradiol production. The result is a reversible hypogonadotropic amenorrhea.
This is why the prediction is biologically plausible, but it also limits its value. Amenorrhea is already seen as an on-target effect of goserelin in its existing endometriosis and breast cancer uses. It serves there as a marker of ovarian suppression, or as ovarian protection during chemotherapy. Whether amenorrhea is a treatment goal (for example, controlling abnormal uterine bleeding) or an adverse effect depends on the clinical context. It is therefore better viewed as a research question than as a new, separate indication.
Two other predictions (renal hypoplasia and bilateral renal hypoplasia, scores about 0.9906) have no clinical or literature support and no plausible mechanistic link to GnRH agonism. They are likely TxGNN model (deep learning) artefacts and are not pursued here.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT02132390 | Phase 3 | Unknown | 300 | Adjuvant toremifene with or without goserelin in premenopausal women with hormone receptor-positive breast cancer, with or without chemotherapy-induced amenorrhoea. Amenorrhea is not the primary target, and no verified efficacy data are available for it. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 12488406 | 2002 | RCT | J Clin Oncol | Goserelin versus CMF chemotherapy as adjuvant therapy in premenopausal node-positive breast cancer (ZEBRA study) |
| 14679153 | 2003 | RCT | J Natl Cancer Inst | Chemotherapy followed by goserelin versus either alone in premenopausal node-negative breast cancer (IBCSG Trial VIII) |
| 17159194 | 2007 | RCT (secondary analysis) | J Clin Oncol | Impact of chemotherapy, goserelin, or both on amenorrhea, hot flashes and quality of life |
| 21325445 | 2011 | RCT (long-term follow-up) | Ann Oncol | Long-term results of IBCSG Trial VIII comparing chemotherapy, goserelin and their combination |
| 28472240 | 2017 | Review/Meta-analysis | Ann Oncol | OPTION trial: GnRH agonist for protection against chemotherapy-induced premature ovarian insufficiency |
| 8513962 | 1993 | RCT | Fertil Steril | Goserelin versus low-dose oral contraceptive for pelvic pain in endometriosis |
| 1533675 | 1992 | Review | J R Army Med Corps | Therapeutic induction of amenorrhoea, including goserelin as an option |
| 12353820 | 2002 | Review | Breast Cancer Res Treat | LHRH agonists in early breast cancer and the benefits of reversible ovarian ablation |
| 12734855 | 2003 | Review | Br J Surg | Methods of ovarian ablation in adjuvant treatment of premenopausal breast cancer |
| 16889194 | 2006 | Prospective study | Akush Ginekol | Zoladex for 6 months in 112 women with pelvic endometriosis |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 246601 | Zoladex 3.6 Injection (AstraZeneca) | Vial of 1 injection | Not stated |
| 246720 | Zoladex LA 10.8mg Injection (AstraZeneca) | Prefilled syringe of 1 injection | Not stated |
| 96288 | Goselin 3.6mg Injection (Bharat Serums & Vaccines Ltd) | Vial of 1 injection | Not stated |
Safety Considerations
- Disease associations flagged in the knowledge graph (not label text): hypertension and hypertensive disorder, hyperglycaemia, diabetes mellitus, diabetic ketoacidosis, hypercalcaemia, nephrocalcinosis, phosphorus metabolism disease, obesity (including monogenic obesity), and urinary tract obstruction.
- Drug interactions: 371 interactions were identified. Among those listed, the one rated Major is dolasetron. Most others are rated Moderate, notably antidiabetic agents (e.g., metformin, glimepiride, chlorpropamide, acarbose, and the DPP-4, SGLT2 and GLP-1 classes), as well as clarithromycin, famotidine, palonosetron, loperamide and several laxatives and bowel-preparation agents.
Please refer to the package insert for warnings and contraindications, as label-based data were not available.
Conclusion and Next Steps
Decision: Hold
Rationale: Amenorrhea is an expected pharmacological consequence of GnRH agonist therapy, not a separate indication. The only trial is of low relevance (status unknown), and the literature is mostly in breast cancer and endometriosis. The evidence is L3 at best.
To proceed, the following is needed:
- A clear definition of the intended use (for example, controlling abnormal uterine bleeding versus fertility protection during chemotherapy)
- Package insert warnings and contraindications for the marketed Indian products
- Approved-indication text for the three Indian licences
- Formal mechanism of action data
- Targeted studies in the defined use, with attention to hormone-deficiency effects such as bone loss and menopausal symptoms
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.