Depot leuprorelin acetate versus danazol in the treatment of infertile women with symptomatic endometriosis.

M Rotondi, Dan Labriola, D Labriola, Mario Rotondi, F P Ammaturo, Franco Pietro Ammaturo, G Amato, Giuseppe Amato, C Carella, Carlo Carella, A Izzo, Andrea Izzo, S Panariello
European journal of gynaecological oncology · 2002 · vol. 23(6) , pp. 523–6 · PMID:12556096 · W153273896
article OA: closed CC0 ⤵ 28 in-corpus citations
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⚙ AI-generated summary by claude@2026-06, 2026-06-07 ⓘ

This randomized trial found depot leuprorelin acetate and danazol effectively treated endometriosis in infertile women, with leuprorelin having fewer withdrawals and more hypoestrogenic side effects compared to danazol's androgenic effects.

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Abstract

PURPOSE OF INVESTIGATION: Endometriosis is a common finding in women with infertility, but the mechanism by which it renders a woman infertile remains unclear. The medical treatment of pelvic endometriosis includes hormonal therapy that directly attacks endometriosis lesions or indirectly by inhibiting endometrial proliferation through estrogenic deprivation. The aim of this study was to compare the efficacy and safety of leuprorelin acetate depot and danazol for endometriosis in infertile women. METHODS: This randomized trial involved 81 women 19-41 years old with regular menses and known pelvic endometriosis who were recruited from the Fertility Center of the Second University of Naples between 1992 and 1999. Fifty-four women were given 3.75 mg of leuprolide acetate depot every 28 days for 24 weeks and the remaining 27 took 200 mg of danazol three times daily for 24 weeks. Efficacy assessments were based on pre-admission and end-of-treatment laparoscopic scores and subjective symptoms scores at 4-week intervals during and after treatment. Safety was evaluated by adverse events and clinical laboratory tests. RESULTS: In each group, endometriosis growth and symptoms significantly improved during treatment (p < 0.001). Significantly fewer patients randomized to leuprorelin acetate (5.5%) withdrew during treatment compared with 18.5% randomized to danazol (p < 0.05). After treatment symptoms returned in each group, but severity was less than at admission at all time points (p < 0.02). Hypoestrogenic side-effects were more common in those receiving leuprorelin, particularly hot flushes, but anabolic/androgenic side-effects of weight gain and acne were more common in those receiving danazol. CONCLUSION: Both leuprorelin acetate depot and danazol are effective in the treatment of endometriosis in infertile patients. The hypoestrogenic side-effects of leuprorelin may be better tolerated than the androgenic, anabolic effects of danazol.

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Condition tags

endometriosisinfertility

MeSH descriptors

Antineoplastic Agents, Hormonal Danazol Endometriosis Estrogen Antagonists Leuprolide Administration, Oral Adult Antineoplastic Agents, Hormonal Danazol Delayed-Action Preparations Endometriosis Endometriosis Estrogen Antagonists Female Humans Infertility, Female Leuprolide Severity of Illness Index Treatment Outcome

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