Revisiting the role of danazol in the contemporary management of endometriosis-related pain: a systematic review

Giani M, Milo Giani, Tucci C, Claudia Tucci, Virginia Manzi, Manzi V, Carlotta Campatelli, Campatelli C, Silvia Vannuccini, Felice Petraglia
Expert opinion on pharmacotherapy · 2026 · vol. 27(14) , pp. 1709–1721 · doi:10.1080/14656566.2026.2726518 · PMID:42663586 · W7204534942
Systematic review / meta-analysis OA: closed public-domain-us
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This systematic review of thirty studies confirms that danazol consistently reduces endometriosis-associated pain, with lower-dose regimens potentially offering a favorable efficacy and tolerability balance for carefully selected patients.

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Abstract

INTRODUCTION: Danazol is a synthetic steroid approved in 1976 for the treatment of endometriosis-associated pain. Despite its established efficacy, its clinical use has markedly declined due to androgenic and metabolic adverse effects, prompting reconsideration of its role in current practice. METHODS: A systematic review was conducted according to PRISMA guidelines and registered in PROSPERO. Six electronic databases were searched up to June 2025 for studies evaluating oral danazol in women with endometriosis. Thirty studies (1,486 patients), including 22 randomized trials, were included. RESULTS: Danazol was evaluated across a wide range of dosing regimens, although most studies used 600 mg/day for 6 months. Consistent reductions in dysmenorrhea, dyspareunia and chronic pelvic pain were reported across the majority of studies. Amenorrhea rates generally increased with higher doses, whereas treatment discontinuation due to adverse events ranged from 0 to approximately 14%. Symptom recurrence after treatment discontinuation was frequently observed. Overall risk of bias was low to moderate. CONCLUSIONS: Danazol demonstrates consistent efficacy in reducing endometriosis-associated pain. Although high-dose regimens are limited by adverse effects, limited evidence suggests that lower-dose regimens may offer a more favorable balance between efficacy and tolerability. These findings support a reappraisal of danazol as a therapeutic option for carefully selected patients within contemporary management strategies. PROTOCOL REGISTRATION: International Prospective Register of Systematic Reviews (PROSPERO), CRD420251088044. Available at: https://www.crd.york.ac.uk/prospero.

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MeSH descriptors

Danazol Danazol Danazol Danazol Danazol Danazol Danazol Danazol Danazol Danazol Danazol Danazol Danazol Danazol Danazol Danazol Danazol Endometriosis Endometriosis Endometriosis

Citation neighborhood (2-hop)

Papers in the corpus that this work cites (lower rings, blue) and that cite this one (upper rings, green). Dot size scales with the paper's in-corpus citation count — bigger dot = more influential within the endo/adeno field. Click a dot to open that paper. Outer rings show 2-hop neighbours — papers reached through the immediate citers/citees. [ collapse to 1-hop ]

References (47)

SciLite annotations

chemicals 6
danazol danazol steroid danazol danazol danazol

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