{"paper_id":"d67e263a-86b6-462f-ab33-e525b1baf732","body_text":"1/5\nORIGINAL ARTICLE\nBrJP . 2025, v.8:e20250042 ● https://doi.org/10.63231/2595-0118.20250042-en\n This is an Open Ac cess article distributed under the terms of the Creative Commons Attribution license  \n(https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.\nHIGHLIGHTS\n• The eff ectiveness of dienogest in the treatment of pain of deep endometriosis\n• Endome trial thickness is directly related to dysmenorrhea\n• Ther e was no correlation between endometrial thickness and other pain symptoms\nEvaluation of endometrial thickness and pain symptoms in women \nwith deep endometriosis using dienogest: retrospective cohort\nAvaliação da espessura endometrial e sintomas de dor em mulheres com endometriose profunda \nusando dienogeste: coorte retrospectiva\nDanielle Mutta1 , João Paulo Leonardo Pinto1 , Cristina Laguna Benetti-Pinto1 , Daniela Angerame Yela1 \n1. Universidade de Campinas \n(UNICAMP), Faculdade de \nMedicina, Campinas, SP , Brasil.\nCorrespondence to:  \nDaniela Angerame Yela  \nyela@unicamp.br\nSubmitted on:  \nOctober 9, 2024.  \nAccepted for publication on:  \nJuly 23, 2025 .\nConflict of interests:  \nnone.\nSponsoring sources:  \nnone.\nData availability:\nThe data that support the \nfindings of this study are \navailable on request from the \ncorresponding author. The data \nare not publicly available due to \nprivacy or ethical restrictions.\nAssociate editor in charge:  \nAnita Perpetua Carvalho Rocha \nde Castro \nABSTRACT\nBACKGROUND AND OBJECTIVES: Endometriosis is a chronic, inflammatory and estrogen-dependent disease. The most \ncommon symptoms include dysmenorrhea, dyspareunia, chronic pelvic pain and infertility. The study’s objective is to evaluate \nthe effect of dienogest on endometrial thickness and correlate it with pain symptoms in women with deep endometriosis.\nMETHODS: Retrospective cohort study with 104 women diagnosed with deep endometriosis from a tertiary hospital from \n2018 to 2022. The variables of sociodemographic characteristics of women, pain symptoms at the beginning of treatment \nwith dienogest and after one year, in addition to the endometrial thickness measured by ultrasound were evaluated at the \nbeginning of treatment and after one year of using dienogest.\nRESUL TS: The average age of the women was 36.0±6.3 years, the majority were white (81.7%), nulliparous (44.2%), with a \npartner (68.2%) and with a body mass index of 27.6± 5.4 kg/m2. Among the study participants, 41.3% had undergone previous \nsurgeries and only 15.3% had another comorbidity. There was better control of dysmenorrhea (p<0.001) and dysuria (p=0.031) \nwith the use of dienogest. The greater the endometrial thickness, the greater the dysmenorrhea (p=0.04). There was no \ncorrelation between endometrial thickness and other pain symptoms.\nCONCLUSION: The use of dienogest for 12 months reduced dysmenorrhea and dysuria but did not reduce other pain complaints. \nEndometrial thickness is directly related to dysmenorrhea.\nKEYWORDS: Dysmenorrhea, Pelvic pain, Endometriosis.\nRESUMO\nJUSTIFICATIVA E OBJETIVOS: A endometriose é uma doença crônica, inflamatória e dependente de estrogênio. Os sintomas \nmais comuns incluem dismenorreia, dispareunia, dor pélvica crônica e infertilidade. O objetivo do estudo foi avaliar o efeito \ndo dienogeste na espessura endometrial e correlacioná-lo com os sintomas de dor em mulheres com endometriose profunda.\nMÉTODOS: Estudo de coorte retrospectivo com 104 mulheres diagnosticadas com endometriose profunda de um hospital \nterciário de 2018 a 2022. Foram avaliadas as variáveis   c aracterísticas sociodemográficas das mulheres, sintomas de dor no \ninício do tratamento com dienogeste e após um ano, além da avaliação da espessura endometrial medida por ultrassonografia \nno início do tratamento e após um ano de uso do dienogeste.\nRESUL TADOS: A média de idade das mulheres foi de 36,0±6,3 anos, a maioria era branca (81,7%), nulípara (44,2%), com \ncompanheiro (68,2%) e apresentava índice de massa corporal de 27,6±5,4 kg/m2. Entre as participantes, 41,3% haviam passado \npor cirurgias prévias e apenas 15,3% apresentavam outra comorbidade. Houve melhor controle da dismenorreia (p<0,001) \ne da disúria (p=0,031) com o uso do dienogeste. Quanto maior a espessura endometrial, maior a dismenorreia (p=0,04). Não \nhouve correlação entre a espessura endometrial e outros sintomas de dor.\nCONCLUSÃO: O uso do dienogeste por 12 meses reduziu a dismenorreia e a disúria, mas não reduziu outras queixas de dor. \nA espessura endometrial está diretamente relacionada à dismenorreia.\nDESCRITORES: Dismenorreia, Dor pélvica, Endometriose.\n\n2/5\nBrJP . 2025, v.8:e20250042 ● Mutta D, Pinto JPL, Benetti-Pinto CL, Yela DA\nINTRODUCTION\nEndometriosis is a chronic, inflammatory and estrogen-\ndependent disease. It is defined by the presence of endometrial \ntissue, gland and/or stroma outside the uterine cavity, mainly \nin places such as the pelvis, ovaries and rectovaginal septum. It \naffects around 200 million women worldwide. The most common \nsymptoms include dysmenorrhea, dyspareunia, chronic pelvic pain \nand infertility, being a debilitating condition that can affect the \nquality of life of affected women1. Studies report a reduction of \napproximately 38% in the productivity of these women, attributed \nmainly to pelvic pain. Furthermore, around 88% of them have \nanxiety or depression disorders1-5.\nConsidered a chronic disease, endometriosis requires long-\nterm treatment that is effective and presents few adverse effects \nto postpone and/or avoid surgical procedures, either due to the \nhigh morbidity or the high recurrence rate of endometriosis, \nwhich is approximately 40%-50% in five years6.\nThe modern treatment of endometriosis must be individualized \nand patient-centered, with a multidisciplinary approach. \nPharmacological treatment is often the choice to begin treatment. \nClinical treatment has been shown to be effective in controlling \npelvic pain and should be the treatment of choice in the absence \nof absolute indications for surgery. It is done using combined \noral contraceptives, danazol, GnRH agonists and progestins7,8. \nA good response to drug treatment improves women’s quality \nof life and reduces surgical treatment, which can lead to several \ncomplications for them.\nAmong the progestins, there is dienogest, which is a fourth-\ngeneration selective progesterone that combines the pharmacological \nproperties of 19-nortestosterone and progesterone derivatives, \nacting on endometriosis lesions with minimal metabolic impact \nand little hormonal action. It has strong action on progesterone \nreceptors and transforms a proliferative endometrium, induced \nby estrogen, into a secretory endometrium, causing, in the long \nterm, endometrial atrophy. The mechanism of action of dienogest \nin endometriosis involves a moderate inhibition of gonadotropin \nsecretion, which reduces endogenous estradiol production. This \ninduction into a state of hypoestrogenism leads to decidualization and \nsubsequent atrophy of the endometrial implants. Some exploratory \nmodels also demonstrate that dienogest has antiproliferative, anti-\ninflammatory and antiangiogenic effects. In vitro and animal \nstudies show that dienogest has a direct inhibitory effect on \nthe proliferation of endometrial-like tissue independent of the \nprogesterone receptor9-11.\nEndometrial thickness, measured on transvaginal ultrasound, \nreflects the overall effect of estrogen stimulation on the endometrial \nglands and stroma, therefore, it could theoretically be used to \nevaluate the efficacy of hormonal therapy in inhibiting estrogenic \nstimulation, suppressing proliferation, and inflammatory changes in \nthe ectopic endometrium. A thin endometrium reflects atrophy of \nthe endometrial gland and stroma, while a thick endometrium may \nbe the sign of an incomplete suppression of hormonal stimulation \nand is therefore responsible for a greater risk of disease progression \nand symptoms. Thus, the assessment of endometrial thickness \ncan evaluate the response to the use of progestogen hormone \ntherapy by reducing pain symptoms12. It is not known whether a \nreduction in endometrial thickness would be correlated with an \nimprovement in pain symptoms in women with endometriosis. \nTherefore, the objective of this study was to evaluate the effect \nof dienogest on endometrial thickness and correlate it with pain \nsymptoms in women with deep endometriosis.\nMETHODS\nRetrospective cohort study with 104 women with deep \nendometriosis followed at the endometriosis outpatient clinic of a \ntertiary hospital from 2018 to 2022. Women of reproductive age, \nwith an ultrasound diagnosis of deep endometriosis and using \ndienogest 2 mg per day for at least one year, who had an ultrasound \nassessing endometrial thickness and who had pain scores assessed \nby the V AS were included. Women were excluded if they did not \nGRAPHICAL ABSTRACT\n\n\n3/5\nBrJP . 2025, v.8:e20250042 ● Mutta D, Pinto JPL, Benetti-Pinto CL, Yela DA\nat 80%. Based on the results, a minimum sample of n=104 women \nwere estimated12.\nRESUL TS\nThe women’s average age was 36.0±6.3 years, the majority were \nwhite (81.7%), nulliparous (44.2%), with a partner (68.2%) and \nhad a body mass index of 27.6±5.4 kg/m2. Among the participants, \n41.3% had undergone previous surgeries and only 15.3% had \nanother comorbidity (Table 1).\nThere was better control of dysmenorrhea (p<0.001) and dysuria \n(p=0.031) with the use of dienogest. There was no significant \ndifference in uterine volume and endometrial thickness after \nusing dienogest for 12 months (p=0.097 and 0.154 respectively). \nThere was a reduction in left ovarian volume (p=0.002) and an \nincrease in right ovarian volume (p=0.044) (Table 2).\nEndometrial thickness was directly proportional to dysmenorrhea \n(p=0.04). There was no correlation between endometrial thickness \nand other pain symptoms such as chronic pelvic pain, dyspareunia \nand dyschezia (Table 3).\nDISCUSSION\nIn the present study, there was no reduction in endometrial \nthickness. Endometrial thickness was directly proportional to \ndysmenorrhea and there was no correlation between endometrial \nthickness and other pain symptoms. The study evaluated 510 \nmedical records of women with endometriosis who were followed \nup at the endometriosis outpatient clinic of the tertiary hospital in \norder to select 104 medical records of women with endometriosis \nusing dienogest for 12 months.\nWomen were on average 36 years old and presented a reduction \nin some pain symptoms. In the literature, another Brazilian study \nshowed equal mean age and a reduction in all pain symptoms with \nthe use of dienogest for 12 months13. Other studies also present \nwomen in the same age group and with a reduction in some or \nall pain symptoms with the use of dienogest for 6 months 14,15. \nA Taiwanese study also showed that the use of dienogest for 12 \nmonths was effective in controlling pain and reducing ovarian \nendometrioma16.\npresent data in the medical record necessary to adequately fill out \nthe study information, who suspended or replaced the medication \nbefore the proposed period or who underwent hysterectomy \nsurgery before completing 12 months of treatment.\nAll variables were evaluated from the medical records. The \nvariables analyzed were age, color (white and non-white), marital \nstatus (with and without a partner), parity, BMI, pain symptoms \n(dysmenorrhea, dyspareunia, chronic pelvic pain, dyschezia and \ndysuria), previous surgeries, comorbidities (systemic arterial \nhypertension, diabetes mellitus, hypothyroidism) and ultrasound \ndescription (uterine volume, ovarian volume), presence of \nendometriosis lesions (anterior cul-de-sac, posterior cul-de-sac, \nintestine, bladder, ovarian endometrioma, adenomyosis), endometrial \nthickness, number of endometriosis lesions.\nPain symptoms were assessed using V AS, where zero is the \nabsence of pain and 10 is the most intense pain. The pain scale \nwas applied at the beginning of the woman’s follow-up in the \nservice before starting to use dienogest and after one year of \nfollow-up using dienogest. The scale was applied by the doctor \nwho treated the woman. Pain symptoms and ultrasound results \nwere assessed at baseline and after 12 months of dienogest use. \nAll other variables were assessed only at baseline.\nEndometrial thickness was assessed by transvaginal pelvic \nultrasonography after adequate bowel preparation, performed by \nthe same radiologist who has more than ten years of experience. \nToshiba X or Volusson E8 devices were used. For this examination, \nbowel preparation (home use) was performed with four bisacodyl \ntablets one day before the examination. Endometrial thickness \nwas described in millimeters. Ultrasounds were performed at \nthe beginning of the women’s follow-up and after one year of \nfollow-up using the medication dienogest.\nThis research was approved by the institution’s Research Ethics \nCommittee under number: 53195521.3.0000.5404. STROBE \nguidelines were followed.\nStatistical analysis\nTo describe the sample profile according to the variables under \nstudy, frequency tables were created for the categorical variables \nwith absolute frequency (n) and percentage (%), and descriptive \nstatistics for the numerical variables with mean, standard deviation, \nminimum and maximum, median and quartiles. To compare \ncategorical variables, the McNemar test was used for related \nsamples. To compare numerical variables, the Wilcoxon test was \nused. To analyze the relationship between pain symptoms and \nultrasound results, Spearman’s correlation coefficient was used, \ndue to the lack of normal distribution of the variables. The level of \nsignificance adopted for the statistical tests was 5%. The software \nused for statistical analysis was Statistical Analysis System – 9.2. \n(SAS Institute Inc, 2002-2008, Cary, NC, USA).\nThe calculation of the sample size for the purpose of comparing \nthe average pain delta (using the V AS) between the endometrial \nthickness groups (smaller thickness and greater thickness) of \nwomen with endometriosis, with estimates obtained from the \nliterature, setting the level of significance at 5% and sample power \nTable 1. Clinical and sociodemographic characteristics of women with \ndeep endometriosis (n=104).\nVariables Mean±SD/n(%)\nAge (years) 36.0±6.3\nNulliparous 51 (44.2)\nWhite 85 (81.7)\nWith partner 71 (68.2)\nBMI (kg/m2) 27.6±5.4\nPrevious surgeries 43 (41.3)\nComorbidities 16 (15.3)\nSD = standard deviation; BMI = body mass index.\n\n4/5\nBrJP . 2025, v.8:e20250042 ● Mutta D, Pinto JPL, Benetti-Pinto CL, Yela DA\nA trial that evaluated women using dienogest alone and \ndienogest in combination with estrogen showed that these \nmedications are effective for pain control, with two-thirds of \nwomen not needing other medications to control symptoms17. \nAnother trial that also evaluated women using dienogest alone and \ndienogest in combination with estrogen for 12 months showed that \ndienogest was effective in controlling pain and reducing ovarian \nendometriomas, reducing the need for surgery in 30% of cases18.\nIn the present study, there was a reduction in pain symptoms, \nbut significantly in the symptoms of dysmenorrhea and dysuria. \nAn Italian study that followed women using dienogest for a long \nterm (36 months) also showed similar results, with a reduction in \npain symptoms, but a significant reduction only in the symptoms \nof dysmenorrhea and dysuria19.\nPain is defined as an unpleasant sensory and emotional \nexperience associated with, or resembling that associated with, \nactual or potential tissue damage. The definition should be valid \nfor acute and chronic pain and apply to all pain conditions, \nregardless of their pathophysiology (e.g., nociceptive, neuropathic, \nand nociplastic). Secondly, the definition of pain should be \napplicable to humans and non-human animals. Thirdly, pain \nwas to be defined whenever possible from the perspective of the \none experiencing the pain, rather than an external observer 20. \nThus, pain has a multidimensional aspect that depends on several \naspects for its assessment.\nThere was no reduction in endometrial thickness in the present \nstudy. This is due to the fact that women were already using other \ntreatments before being included in the study. In the literature, \na measurable reduction in endometrial thickness has previously \nbeen described in women undergoing medical treatment for \nendometriosis with GnRH (gonadotropin-releasing hormone) \nanalogues or levonorgestrel-releasing intrauterine devices and \nthis change reflects both the absence of estrogenic stimulation \nin therapies that induce hypoestrogenism, regarding the effect of \nprogestins causing glandular atrophy and reduction in vascular \ndensity21.\nAs this study is retrospective, there are limitations such as: lack \nof information in medical records, discontinuation of treatment \nby some women after only a few months of the pharmacological \ntreatment, lack of imaging tests before or after treatment, the study \nsite being a tertiary health care service where many women begin \nfollow-up already undergoing treatment and the evaluation period \nencompassed the years of the Covid-19 pandemic, which reduced \nthe number of visits to the service as a safety measure for women.\nThe result of this study is consistent with the existing literature, \ndespite corresponding to only one study that evaluates endometrial \nthickness, in which there is control of dysmenorrhea with the \ncontinuous use of dienogest and the correlation of the smaller the \nendometrial thickness, the better the control of dysmenorrhea22.\nCONCLUSION\nUse of dienogest reduced dysmenorrhea and dysuria, but \ndid not reduce other pain complaints and also did not reduce \nendometrial thickness. Endometrial thickness is directly related to \ndysmenorrhea. Endometriosis represents a significant global health \nchallenge due to its high incidence in women of reproductive age. \nTable 3. Correlation of pain symptoms with endometrial thickness in women with deep endometriosis before and after treatment with dienogest (n=104).\nDysmenorrhea Chronic pelvic pain Dyspareunia Dyschezia Dysuria\nEndometrial thickness initial\nR 0.20 -0.10 -0.05 -0.19453 0.02\nP 0.041 0.326 0.617 0.0549 0.041\nEndometrial thickness final\nR 0.18 0.15 0.11 0.09 0.02\nP 0.068 0.138 0.252 0.372 0.821\nR = Spearman correlation coefficient; P = p-value.\nTable 2. Assessment of pain symptoms and ultrasound results of women with deep endometriosis using dienogest for 12 months (n=104).\nInitial 12 months\np-value\nMean± SD Mean± SD\nDysmenorrhea 4.0±4.1 2.1±3.5 < 0.001\nChronic pelvic pain 3.7±3.9 2.9±3.6 0.074\nDyspareunia 2.6±3.3 2.5±3.2 0.746\nDyschezia 2.1±3.3 1.7±3.2 0.200\nDysuria 0.8±2.3 0.3±1.4 0.031\nUterine volume (mm3) 95.6±52.2 98.6±99.6 0.097\nLeft ovarian volume (mm3) 32.1±80.4 20.0±44.5 0.002\nRight ovarian volume (mm3) 19.7±44.6 29.9±159.8 0.044\nEndometrial thickness (mm) 4.5±2.3 4.2±2.2 0.154\nSD = standard deviation; Wilcoxon test.\n\n5/5\nBrJP . 2025, v.8:e20250042 ● Mutta D, Pinto JPL, Benetti-Pinto CL, Yela DA\nIn addition, this condition is a major cause of impaired quality of \nlife due to pain symptoms. Given this context, it is imperative that \nmore research be conducted into this disease to ensure adequate \ntreatment for pain control.\nREFERENCES\n1. 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