Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial.

Pedro Acién, Irene Velasco, Maribel Acién
In: Research Square · 2020 · doi:10.21203/rs.3.rs-51837/v3 · W4242797033
preprint OA: green CC0
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⚙ AI-generated summary by claude@2026-06, 2026-06-08 ⓘ

Anastrozole plus a levonorgestrel-releasing intrauterine device for six months before surgery significantly reduced endometriosis symptoms and recurrence compared to LNG-IUD alone or with TUGPA.

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⚙ AI-generated deep summary by claude@2026-06, 2026-06-09 ⓘ

This randomized clinical trial studied whether 6 months of the aromatase inhibitor anastrozole (1 mg/day) added to a levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena) improves outcomes in premenopausal women with symptomatic endometriomas (>3×4 cm) and elevated CA-125, compared with LNG-IUD alone, in combination with either conservative surgery (ovarian and fertility-sparing) or transvaginal ultrasound-guided puncture-aspiration (TUGPA). Thirty-one women were assigned to anastrozole+Mirena plus conservative surgery, anastrozole+Mirena plus TUGPA, Mirena plus conservative surgery, or Mirena plus TUGPA, and outcomes included symptom visual analog scale, CA-125, ultrasound findings, and recurrences, with follow-up up to about 4 years. Symptoms improved significantly during treatment and the improvement was maintained at 1 and 2 years, with larger symptom improvement in the anastrozole groups, while the greatest CA-125 decrease was observed in patients without anastrozole; conservative surgery reduced endometrioma findings and long-term recurrences, with far higher proportions of asymptomatic patients than TUGPA. The main caveat is that the study is single-center, small (n=31), and preprint status indicates it has not been peer reviewed, which may limit generalizability. This paper is centrally about endometriosis — a randomized trial evaluating anastrozole plus LNG-IUD, alone or combined with conservative surgery or TUGPA, for endometriosis symptoms and endometrioma outcomes.

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Abstract

Abstract Background: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated to levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis. Methods: Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences. Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed without anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena®+anastrozole). After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole. At 4,2±1,7 years (95% CI 3,57-4,85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019). Conclusions: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective.

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endometriosis

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