Levonorgestrel-releasing intrauterine system for endometrial hyperplasia.
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ABSTRACT:
SUBMITTER: Mittermeier T
PROVIDER: S-EPMC8200645 | biostudies-literature | 2020 Sep
REPOSITORIES: biostudies-literature
Publications
Levonorgestrel-releasing intrauterine system for endometrial hyperplasia.
Mittermeier Theresa T Farrant Charlotte C Wise Michelle R MR
The Cochrane database of systematic reviews 20200906
<h4>Background</h4>In the absence of treatment, endometrial hyperplasia (EH) can progress to endometrial cancer, particularly in the presence of histologic nuclear atypia. The development of EH results from exposure of the endometrium to oestrogen unopposed by progesterone. Oral progestogens have been used as treatment for EH without atypia, and in some cases of EH with atypia in women who wish to preserve fertility or who cannot tolerate surgery. EH without atypia is associated with a low risk ...[more]
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Project description:ObjectiveTo assess efficacy of the levonorgestrel-releasing intrauterine device (LNG-IUD) for treatment of complex atypical hyperplasia or low-grade endometrial cancer.MethodsThis retrospective case series included all patients treated with the LNG-IUD for complex atypical hyperplasia or early-grade endometrial cancer from January 2003 to June 2013. Response rates were calculated and the association of response with clinicopathologic factors, including age, body mass index, and uterine size, was determined.ResultsForty-six patients diagnosed with complex atypical hyperplasia or early-grade endometrial cancer were treated with the LNG-IUD. Of 32 evaluable patients at the 6-month time point, 15 had complex atypical hyperplasia (47%), nine had G1 endometrial cancer (28%), and eight had grade 2 endometrial cancer (25%). Overall response rate was 75% (95% CI 57-89) at 6 months; 80% (95% CI 52-96) in complex atypical hyperplasia, 67% (95% CI 30-93) in grade 1 endometrial cancer, and 75% (CI 35-97) in grade 2 endometrial cancer. Of the clinicopathologic features evaluated, there was a trend toward the association of lack of exogenous progesterone effect in the pathology specimen with nonresponse to the IUD (P=.05). Median uterine diameter was 1.3 cm larger in women who did not respond to the IUD (P=.04).ConclusionLevonorgestrel-releasing IUD therapy for the conservative treatment of complex atypical hyperplasia or early-grade endometrial cancer resulted in return to normal histology in a majority of patients.
| S-EPMC5739955 | biostudies-literature
Project description:ObjectiveTo investigate relapse rates after the successful treatment of patients with non-atypical endometrial hyperplasia who were randomised to either a levonorgestrel-impregnated intrauterine system (LNG-IUS; Mirena(®) ) or two regimens of oral medroxyprogesterone acetate (MPA) after primary histological response.DesignA multicentre randomised trial.SettingTen different outpatient clinics localised in hospitals and seven gynaecological private practices in Norway.PopulationOne hundred and fifty-three women aged 30-70 years with low- or medium-risk endometrial hyperplasia met the inclusion criteria, and 153 completed the therapy.MethodsPatients were randomly assigned to one of the following three treatment arms: LNG-IUS; 10 mg of oral MPA administered for 10 days per cycle for 6 months; or 10 mg of oral MPA administered daily for 6 months. The women were followed for 24 months after ending therapy.Main outcome measuresHistological relapse of endometrial hyperplasia.ResultsHistological relapse was observed in 55/135 (41%) women who had an initial complete treatment response. The relapse rates were similar in the three therapy groups (P = 0.66). In the multivariable analyses relapse was dependent on menopausal status (P = 0.0005) and estrogen level (P = 0.0007).ConclusionsThe risk of histological relapse of non-atypical endometrial hyperplasia is high within 24 months of ceasing therapy with either the LNG-IUS or oral MPA. Continued endometrial surveillance and prolonging progestogen therapy should be considered.Tweetable abstractRelapse of endometrial hyperplasia after successful treatment is independent of therapy regime.
| S-EPMC5215722 | biostudies-literature
Project description:ObjectiveTo conduct a systematic review and meta-analysis of studies evaluating the oncological and fertility outcomes of early-stage endometrial cancer (EC) treated with the levonorgestrel-releasing intrauterine system (LIUS)-based regimens.MethodsThe Meta-analyses Of Observational Studies in Epidemiology statement for meta-analyses was followed. Searches were conducted on MEDLINE, Embase, PubMed, Preprints, and the Cochrane Central Register of Controlled Trials from January 1990 to August 4, 2022. The Joanna Briggs Institute Critical Appraisal Checklist was used for quality assessment. The primary endpoint was the complete response (CR) rate and the secondary endpoints were relapse, pregnancy, and live birth rate.ResultsA total of 25 studies (821 women) were included. The CR rate of LIUS-based regimens was 63.4% (95% confidence interval [CI]=52.3%-73.2%), with 29.6% (95% CI=23.3%-36.8%) of cases experiencing recurrence during follow-up. In sensitivity analyses, patients younger than 45 years of age with a body mass index <30 kg/m² who were treated with LIUS-based regimens achieved a high CR rate of 84.6% (95% CI=80.3%-88.1%) over a median follow-up of more than 24 months. Overall pregnancy and live birth rates were 37.9% (95% CI=24.1%-53.9%) and 39.3% (95% CI=24.0%-57.0%), respectively. No statistical differences were apparent in CR or relapse rates among the LIUS+GnRH agonist, LIUS+oral progesterone, or hysteroscopic resection followed by LIUS subgroups.ConclusionLIUS-based therapies are viable for the conservative management of early-stage endometrioid EC on CR and fertility outcome.Trial registrationPROSPERO Identifier: CRD42022352890.
| S-EPMC9995869 | biostudies-literature
Project description:ObjectiveThe purpose of this study was to investigate if the levonorgestrel-impregnated intrauterine device (LNG-IUS, Mirena(®) ) is safe and effective as therapy for low-risk and medium-risk endometrial hyperplasia compared with oral medroxyprogesterone (MPA).DesignA multicentre randomised trial.SettingNorway.PopulationIn all, 170 women aged 30-70 years with low- or medium-risk endometrial hyperplasia who met inclusion criteria.MethodsPatients were randomly assigned to one of three treatment arms: LNG-IUS; oral MPA 10 mg administered for 10 days per cycle, or continuous oral MPA 10 mg daily, for 6 months.Main outcome measuresThe primary outcome measure was normalisation or persisting hyperplasia.ResultsAfter 6 months all three treatment regimens showed significant effect when the outcome was evaluated as therapy response or not (P < 0.001). Responses were obtained for all the women in the LNG-IUS group (53/53, 95% CI 0.93-1.0) and for 96% of the women in the continuous oral group (46/48, 95% CI 0.86-0.99). Only 69% of the women in the cyclic oral group were responders (36/52, 95% CI 0.55-0.81). Adverse effects were relatively common with minimal differences between therapy groups.ConclusionIn the first trial of its kind, women treated with the LNG-IUS showed histologically normal endometrium after 6 months of therapy for endometrial hyperplasia. Cyclical progestogens are found to be less effective compared with continuous oral therapy and LNG-IUS and should not be used for this purpose.
| S-EPMC4155866 | biostudies-literature
Project description:BackgroundThough hysterectomy remains the standard treatment for complex atypical hyperplasia, patients who desire fertility or who are poor surgical candidates may opt for progestin therapy. However, the effectiveness of the levonorgestrel-releasing intrauterine device compared to systemic therapy in the treatment of complex atypical hyperplasia has not been well studied.ObjectiveWe sought to examine differences in treatment response between local progestin therapy with the levonorgestrel-releasing intrauterine device and systemic progestin therapy in women with complex atypical hyperplasia.MethodsThis single-institution retrospective study examined women with complex atypical hyperplasia who received progestin therapy between 2003 and 2018. Treatment response was assessed by histopathology on subsequent biopsies. Time-dependent analyses of complete response and progression to cancer were performed comparing the levonorgestrel-releasing intrauterine device and systemic therapy. A propensity score inverse probability of treatment weighting model was used to create a weighted cohort that differed based on treatment type but was similar with respect to other characteristics. An interaction-term analysis was performed to examine the impact of body habitus on treatment response, and an interrupted time-series analysis was employed to assess if changes in treatment patterns correlated with outcomes over time.ResultsA total of 245 women with complex atypical hyperplasia received progestin therapy (levonorgestrel-releasing intrauterine device n = 69 and systemic therapy n = 176). The mean age and body mass index were 36.9 years and 40.0 kg/m2, respectively. In the patient-level analysis, women who received the levonorgestrel-releasing intrauterine device had higher rates of complete response (78.7% vs 46.7%; adjusted hazard ratio, 3.32; 95% confidence interval, 2.39-4.62) and a lower likelihood of progression to cancer (4.5% vs 15.7%; adjusted hazard ratio, 0.28; 95% confidence interval, 0.11-0.73) compared to those who received systemic therapy. In particular, women with class III obesity derived a higher relative benefit from levonorgestrel-releasing intrauterine device therapy in achieving complete response compared to systemic therapy: class III obesity, adjusted hazard ratio 4.72, 95% confidence interval 2.83-7.89; class I-II obesity, adjusted hazard ratio 1.83, 95% confidence interval 1.09-3.09; and nonobese, adjusted hazard ratio 1.26, 95% confidence interval 0.40-3.95. In the cohort-level analysis, the obesity rate increased during the study period (77.8% to 88.2%, 13.4% relative increase, P = .033) and levonorgestrel-releasing intrauterine device use significantly increased after 2007 (6.3% to 82.7%, 13.2-fold increase, P < .001), both concomitant with a higher proportion of women achieving complete response (32.9% to 81.4%, 2.5-fold increase, P = .005).ConclusionOur study suggests that local therapy with the levonorgestrel-releasing intrauterine device may be more effective than systemic therapy for women with complex atypical hyperplasia who opt for nonsurgical treatment, particularly in morbidly obese women. Shifts in treatment paradigm during the study period toward increased levonorgestrel-releasing intrauterine device use also led to improved complete response rates despite increasing rates of obesity.
| S-EPMC7751571 | biostudies-literature
Project description:BackgroundGlobally, approximately 19.4% of women of reproductive age use intrauterine contraception, encompassing both copper intrauterine devices (Cu-IUDs) and levonorgestrel intrauterine devices (LNG-IUDs). Despite current guidelines endorsing intrauterine contraception as a primary method, there remains debate regarding device selection. Notably, the lack of data regarding reasons for discontinuation has limited previous meta-analyses. This study aims to comprehensively evaluate the potential differences between intrauterine devices using available multinational data, thereby providing a basis for global policy and healthcare services.MethodsWe systematically searched PubMed, EMBASE, Web of Science, and Cochrane Library for primary studies published from inception to January 13, 2024, with no language or geographic restrictions. The study was registered on PROSPERO (CRD42024496400). We included only randomized controlled trials comparing Cu-IUDs and LNG-IUDs. Data extraction was independently conducted by two reviewers, with unresolved discrepancies referred to a third senior reviewer for consultation. The primary outcome was pregnancy, with secondary outcomes encompassing continuation, reasons for discontinuation, expulsion, satisfaction, and other adverse events. Data were synthesized using a random-effects model. Risk of bias was evaluated with the Cochrane Collaboration's tool, and evidence quality was assessed using the GRADE framework.FindingsAn analysis of 20 trials showed that compared to Cu-IUDs, LNG-IUDs were associated with lower risks of pregnancy (Risk Ratio 0.22, 95% confidence interval 0.12-0.39), ectopic pregnancy (RR 0.12, 95% CI 0.03-0.47), discontinuation due to increased bleeding (RR 0.49, 95% CI 0.28-0.85), increased bleeding (RR 0.42, 95% CI 0.25-0.7), heavy bleeding (RR 0.41, 95% CI 0.22-0.75), and dysmenorrhea (RR 0.41, 95% CI 0.34-0.48), but they carried a higher risk of discontinuation due to amenorrhea (RR 21.05, 95% CI 8.83-50.00). When comparing LNG (52 mg) IUD with copper (380 mm2) IUD, The LNG-IUD showed a lower risk of discontinuation due to increased bleeding (RR 0.68, 95% CI 0.55-0.58) and dysmenorrhea (RR 0.42, 95% CI 0.34-0.53), but a higher risk of discontinuation due to bleeding issues (RR 2.83, 95% CI 2.47-3.25) and amenorrhea (RR 5.92, 95% CI 2.81-12.49). There were no significant differences between the two terms of continuation, expulsion, non-medical reasons for discontinuation, satisfaction, and other adverse outcomes.InterpretationLNG-IUDs and Cu-IUDs are both highly effective contraceptive methods. Compared to Cu-IUDs, LNG-IUDs were associated with a lower risk of pregnancy and adverse reactions. However, LNG-IUDs carry a higher risk of amenorrhea. When recommending contraceptive methods, healthcare providers should fully inform patients of these potential risks and consider patient preferences.FundingThe research was funded by Hunan Provincial Natural Foundation of China (2021JJ30040), the National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University (2021KFJJ06), and the National Natural Science Foundation of China (No. 81672225).
| S-EPMC11602564 | biostudies-literature
Project description:ObjectiveTo simulate hysteroscopic suturing in vitro and analyze the learning curve of gynecologists with different experience levels.MethodsThree gynecologists were trained on uterine models in a circulating water box. The posterior uterine wall was sutured 10 times under hysteroscopy for 5 consecutive days, and the time of each suture procedure was recorded.ResultsDoctors A, B, and C completed 50 posterior uterine sutures. After Dr. C completed 50 sutures on the posterior wall, he added 50 sutures on the anterior wall (Group D). The mean suturing time was 71.54 ± 68.158 s in Group A, 50.10 ± 28.060 s in Group B, 34.04 ± 10.457 s in Group C, and 30.38 ± 8.734 s in Group D. The difference between Groups C and B and between Groups B and A was statistically significant. There was no statistically significant difference between Groups C and D. Simulation curves were created using the number of features as the abscissa and cumulative sum as the coordinate, with peak curves of 19, 27, and 18 cases for Group A, B, and C, respectively.ConclusionDoctors with experience in single-hole laparoscopic surgery or hysteroscopic suture surgery can significantly shorten the hysteroscopic suturing time.
| S-EPMC10590047 | biostudies-literature
Project description:The aim of this review was to summarize the available evidence about the use of levonorgestrel-releasing intrauterine system (LNG-IUS) as a contraceptive method in nulliparous women. For this purpose, studies evaluating the efficacy, safety, bleeding pattern, satisfaction and discontinuation of the levonorgestrel-releasing intrauterine system in nulliparous women were analyzed. Only original research articles published in English between 1990-27th March 2020 were considered eligible. Reviews, book chapters, case studies, conference papers, opinions, editorials and letters were excluded. The systematic literature search of PubMed/MEDLINE, Scopus, Embase and Cochrane Library databases identified 816 articles, 23 of which were analyzed. The available evidence indicates that LNG-IUS is an effective and safe contraceptive method for nulliparous women that achieves high levels of satisfaction among patients. Moreover, nulliparous women seem to experience fewer expulsions than parous ones. Bleeding pattern is acceptable for the majority of patients, and bleeding disorders mainly occur in the first months after the insertion. More in-depth, long-term prospective studies are needed in this patient group to determine risk factors for the occurrence of side effects and associated discontinuations, which should not, however, delay the wider use of the method in this group, given the number of advantages.
| S-EPMC7408997 | biostudies-literature
Project description:BackgroundEndometrial adenocarcinoma (EC) is the fifth most common cancer in women worldwide, standard treatment for EC includes hysterectomy, but it results in the loss of reproductive function. Thus, conservative treatment for these patients is strongly demanded, progestin therapy is widely accepted as the main fertility-sparing treatment for young women with endometrial hyperplasia with atypia (EHA) and well-differentiated endometrioid endometrial cancer. This trial will investigate the effectiveness of conservative treatment for obese women with early-stage EC.Method and designThis will be an open-label, 2-armed, randomized, phase-II single-center trial of LNG-IUD plus metformin or megestrol acetate (MA) plus metformin. A total of 88 participants will be randomly assigned into 2 treatment arms in a 1:1 ratio. Clinical, laboratory, ultrasound and radiology data, will be collected at baseline, and then at 3, 6, 9, 12, 18, and 24 months. EC biomarkers will be collected at baseline. The primary aim is to determine the efficacy of a levonorgestrel-releasing intrauterine device (LNG-IUD) plus metformin, or megestrol acetate (MA) plus metformin in achieving pathological complete response (pCR) at 12 months, as well as post-treatment pregnancy outcomes and recurrence rate. The secondary aims are to predict the response to an LNG-IUD plus metformin and MA plus metformin via clinical, blood, and tissue predictive biomarkers.ConclusionsProspective evidence for conservative treatment of EC is limited. New methods to achieve better CR rates with fewer side effects are needed. This trial will investigate the effectiveness of LNG-IUD plus metformin, and MA plus metformin, in obese women with early-stage EC, providing a non-surgical treatment option for these patients. Trial registration ChiCTR2200055624. The trial was registered at http://www.chictr.org.cn/listbycreater.aspx on January 15, 2022.
| S-EPMC9636609 | biostudies-literature
Project description: Not available
| S-EPMC6543114 | biostudies-literature