Goserelin

證據等級: L5

預測適應症: 10 個

Goserelin: From Unspecified Original Indication to Amenorrhoea

One-Sentence Summary

Goserelin’s original approved indication is not recorded in this Evidence Pack (data gap — original_indications is empty and MOA is flagged as a data gap), though the pack confirms it as a GnRH agonist. The TxGNN model predicts it may be effective for Amenorrhoea (specifically, GnRH-agonist–induced ovarian suppression for chemotherapy-related ovarian protection), with 7 clinical trials and 19 publications currently supporting this direction.

Quick Overview

Item	Content
Original Indication	Not available in this Evidence Pack (no licences or `original_indications` on file — drug is not currently marketed)
Predicted New Indication	Amenorrhoea
TxGNN Prediction Score	99.99%
Evidence Level	L1
Australia Market Status	Not Marketed
Number of ARTG Entries	0
Recommended Decision	Proceed with Guardrails

Why is This Prediction Reasonable?

Currently, a structured mechanism-of-action record is not available for Goserelin in this Evidence Pack (flagged as data gap DG002). However, the indication-specific rationale supplied with the top prediction confirms Goserelin is a GnRH (gonadotropin-releasing hormone) agonist: sustained use desensitises the pituitary, suppressing LH/FSH release, which in turn suppresses ovarian steroidogenesis and induces a hypo-oestrogenic, amenorrhoeic state.

This is not an incidental association — inducing amenorrhoea is a direct pharmacological extension of Goserelin’s known class effect, not a novel or unexpected mechanism. The clinical trial and literature evidence in this pack overwhelmingly relate to using Goserelin during chemotherapy for premenopausal, hormone-sensitive breast cancer to preserve ovarian function — i.e., deliberately inducing reversible amenorrhoea to protect the ovaries from cytotoxic damage. Because this reflects the drug’s core, well-established pharmacology rather than an off-target effect, the mechanistic plausibility of this prediction is very strong, even though the original approved indication itself is not documented in this pack.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrolment	Key Findings
NCT00068601	Phase 3	Completed	257	LHRH analogue (goserelin) plus chemotherapy vs chemotherapy alone to reduce ovarian failure in early-stage, hormone-receptor-negative breast cancer
NCT00427245	Phase 3	Completed	400	OPTION trial: goserelin vs no goserelin for preventing early menopause in premenopausal women undergoing chemotherapy for stage I–III breast cancer
NCT02483767	Phase 3	Completed	98	Randomised trial of GnRH agonist goserelin added to chemotherapy vs chemotherapy alone for preserving ovarian function in premenopausal breast cancer
NCT01218581	Phase 2/3	Completed	32	Aromatase inhibitor vs GnRH agonist for managing uterine adenomyosis in women wishing to preserve fertility
NCT03475758	Phase 2	Unknown	100	Goserelin for ovarian protection during cyclophosphamide-containing chemotherapy; menstruation outcome endpoint
NCT02132390	Phase 3	Unknown	300	Adjuvant toremifene ± goserelin in premenopausal hormone-receptor-positive breast cancer, with/without chemotherapy-induced amenorrhoea
NCT00488722	Not applicable	Unknown	N/A	Single-arm study of Zoladex 3.6 mg plus CEF chemotherapy as neoadjuvant therapy in hormone-responsive premenopausal breast cancer, inducing reversible amenorrhoea

No ANZCTR-registered trial identifiers were found in this Evidence Pack.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
28472240	2017	RCT	Ann Oncol	OPTION trial: GnRH agonist during chemotherapy reduced risk of chemotherapy-induced premature ovarian insufficiency in early breast cancer
26951320	2016	Cohort	J Clin Oncol	Clinical guidance discussion on whether oestradiol monitoring is necessary during goserelin-induced ovarian suppression in breast cancer
25187267	2015	Cohort	Cancer Res Treat	Goserelin-induced ovarian ablation improved survival in stage II/III hormone-receptor-positive breast cancer patients without chemotherapy-induced amenorrhoea
17159194	2007	RCT	J Clin Oncol	IBCSG Trial VIII: chemotherapy followed by goserelin vs either alone — effects on amenorrhoea, hot flashes, and quality of life in premenopausal patients
14679153	2003	RCT	J Natl Cancer Inst	IBCSG Trial VIII: chemotherapy followed by goserelin vs either modality alone in premenopausal node-negative breast cancer
12734855	2003	Review	Br J Surg	Review of ovarian ablation methods, including GnRH agonists, in adjuvant treatment of pre/perimenopausal breast cancer
12488406	2002	RCT	J Clin Oncol	ZEBRA study: goserelin vs CMF chemotherapy as adjuvant therapy in node-positive premenopausal breast cancer
12353820	2002	Review	Breast Cancer Res Treat	Overview of LHRH agonists in early breast cancer, highlighting benefits of reversible ovarian ablation
8513962	1993	RCT	Fertil Steril	Goserelin vs low-dose oral contraceptive for endometriosis-related pelvic pain, demonstrating induced-amenorrhoea mechanism
1533675	1992	Review	J R Army Med Corps	Historical review of therapeutic amenorrhoea induction, including goserelin as a highly effective GnRH-analogue method

Australia Market Information

No ARTG entries were found for Goserelin in this Evidence Pack — market status is recorded as Not Marketed, with 0 licences on file. No product name, dosage form, or approved indication text is available to summarise.

Safety Considerations

Please refer to the TGA-approved Product Information (PI) for safety information. No key warnings, contraindications, or drug interaction data were available in this Evidence Pack (DDI query status: not found).

Conclusion and Next Steps

Decision: Proceed with Guardrails

Rationale: The top-ranked prediction (amenorrhoea, as ovarian protection during chemotherapy) is backed by three completed Phase 3 RCTs and multiple supporting Phase 2/3 and observational studies, all directly testing Goserelin’s core pharmacological action rather than an off-target effect — meeting Evidence Level L1. However, Goserelin is not currently marketed locally and core drug-level safety data (MOA, PI warnings/contraindications) are missing, so this should not proceed without guardrails.

To proceed, the following is needed:

TGA/TFDA-equivalent Product Information (warnings, contraindications) — currently a Blocking data gap (DG001)
Structured mechanism-of-action record for Goserelin — currently a High-severity data gap (DG002)
Confirmation of local regulatory pathway, given the drug is not currently marketed in this jurisdiction
Drug interaction (DDI) data, currently unavailable
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.