Levonorgestrel intrauterine system versus dienogest effect on quality of life of women with deep endometriosis: a randomized open-label clinical trial
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This randomized trial compared the levonorgestrel intrauterine system to dienogest for improving quality of life in women with deep endometriosis who did not undergo surgery.
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Abstract
Women with deep infiltrating endometriosis (DIE) can benefit from the use of progestins. Our aim is to explore if levonorgestrel-releasing intrauterine system (LNG-IUS) non inferior to dienogest (DNG) in improving deep endometriosis women's quality of life (QoL). This randomized open-label clinical trial included forty women with DIE assessed using clinical history and physical examination, transvaginal ultrasonography and magnetic resonance of the pelvis without any previous surgical treatment, with two treatments arms. The two groups underwent a 3-month washout of hormonal treatments, and then received either DNG or LNG-IUS for 6 months. QoL was assessed prior to and 6 months after the intervention, using the SF36 and the EHP30. DNG and LNG-IUS showed an increase on all domains of the SF36 (p .05 for all domains). DNG and LNG-IUS, also, showed improvement on all domains of EHP30 (p .05). The treatment of deep endometriosis symptoms using either DNG or LNG-IUS in women with no prior surgical treatment is associated with improvement in QoL.Trial Registration Number: This trial is registered on "The Brazilian Registry of Clinical Trials (ReBECID: RBR-8fjx2jp)," that is part of Primary Registries in the WHO Registry Network, under the title: "Dienogest versus Levonorgestrel IUS on deep endometriosis patient´s QoL without surgery" on June 14, 2021; https://ensaiosclinicos.gov.br/rg/RBR-8fjx2jp.
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- europepmc
- last seen: 2026-08-31T06:09:41.840111+00:00
- openalex
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- pubmed
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