Increasing utilization and patterns of use of the levonorgestrel intrauterine system — data from a large US health plan (original) (raw)
Related papers
Sri Lanka Journal of Obstetrics and Gynaecology, 2012
Objective: To study effects of levonorgestrel intra-uterine system (LNG-IUS) on adenomyosis with and without endometriosis. Design: Fifty-eight women with a confirmed diagnosis of adenomyosis after exclusion of confounding factors, and detection or exclusion of endometriosis were selected. They were categorized into group A (only adenomyosis, n=44) and group B (adenomyosis plus endometriosis, pre-treated by laparoscopic surgery, n=14) received LNG-IUS between July 2004 and January 2006 and were followed up on five different parameters. Results: Analysis of three years' follow up shows mean reduction of different variables in groups A and B as dysmenorrhoea (visual analogue scale) 98.2±3.9% and 98.3±3.7% (p<0.0001) menstrual bleeding (blood-loss assessment chart) 92.2±11.2% and 85.0±17.5% (p<0.0001), chronic pelvic pain (pain-calendar) 98.8±2.7% and 96.4±4.9% (p<0.0001); uterine volume 27.8±9.0% and 28.7±9.6% (p<0.0005) maximum endo-myometrial junctional-zone thickness 30.2±7.9% and 26.0±4.8% (p<0.0005). Effects on groups A and B were comparable. Other observations were-amenorrhoea-27.5%, intermenstrual bleeding-37.3% and expulsion-6.9%. Conclusion: LNG-IUS is equally effective for long-term conservative management of both adenomyosis alone and with co-existent endometriosis.
2006
Oral contraceptives have long been associated with liver injury. However, very little attention is paid to the metabolic side effects of hormone-releasing intrauterine devices (IUDs). These devices are generally considered safe and commonly used. We report for the first time acute liver injury associated with a levonorgestrel-releasing IUD. Our patient did not have any comorbidities that could have caused or exacerbated liver injury. A detailed workup and liver biopsy remained negative for any other potential cause of liver injury. The patient's symptoms resolved with removal of the device. She remained symptom free on subsequent outpatient follow-ups.
Levonorgestrel-releasing intrauterine system for endometrial hyperplasia
Cochrane Library, 2020
Background: 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 of progression to atypia and cancer; EH with atypia is where the cells are structurally abnormal, and has a higher risk of developing cancer. Oral progestogen is not always effective at reversing the hyperplasia, can be associated with side effects, and depends on patient adherence. The levonorgestrel‐intrauterine system (LNG‐IUS) is an alternative method of administration of progestogen and may have some advantages over non‐intrauterine progestogens. Objectives: To evaluate the effectiveness and safety of the levonorgestrel intrauterine system (LNG‐IUS) in women with endometrial hyperplasia (EH) with or without atypia compared to medical treatment with non‐intrauterine progestogens, placebo, surgery or no treatment. Search methods: We searched the following databases: the Cochrane Gynaecology and Fertility Group (CGF) Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO, and conference proceedings of 10 relevant organisations. We handsearched references in relevant published studies. We also searched ongoing trials in ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry, and other trial registries. We performed the final search in May 2020. Selection criteria: Randomised controlled trials (RCTs) and cross‐over trials of women with a histological diagnosis of endometrial hyperplasia with or without atypia comparing LNG‐IUS with non‐intrauterine progestogens, placebo, surgery or no treatment. Data collection and analysis: Two review authors independently performed study selection, risk of bias assessment and data extraction. Our primary outcome measures were regression of EH and adverse effects associated with the LNG‐IUS device (such as pelvic inflammatory disease, device expulsion, uterine perforation) when compared to treatment with non‐intrauterine progestogens, placebo, surgery or no treatment. Secondary outcomes included hysterectomy, hormone‐related adverse effects (such as bleeding/spotting, pelvic pain, breast tenderness, ovarian cysts, weight gain, acne), withdrawal from treatment due to adverse effects, satisfaction with treatment, and cost or resource use. We rated the overall quality of evidence using GRADE methods. Main results: Thirteen RCTs (1657 women aged 22 to 75 years) met the inclusion criteria. Two studies had insufficient data for meta‐analysis, thus the quantitative analysis included 11 RCTs. All trials evaluated treatment duration of six months or less. The evidence ranged from very low to moderate quality: the main limitations were risk of bias (associated with lack of blinding and poor reporting of study methods), inconsistency and imprecision. LNG‐IUS versus non‐intrauterine progestogens Primary outcomes Regression of endometrial hyperplasia: The LNG‐IUS probably improves regression of EH compared with non‐intrauterine progestogens at short‐term follow‐up (up to six months) (OR 2.94, 95% CI 2.10 to 4.13; I² = 0%; 10 RCTs, 1108 participants; moderate‐quality evidence). This suggests that if regression of EH following treatment with a non‐intrauterine progestogen is assumed to be 72%, regression of EH following treatment with LNG‐IUS would be between 85% and 92%. Regression of EH may be improved by LNG‐IUS compared with non‐intrauterine progestogens at long‐term follow‐up (12 months) (OR 3.80, 95% CI 1.75 to 8.23; 1 RCT, 138 participants; low‐quality evidence). Adverse effects associated with LNG‐IUS: There was insufficient evidence to determine device‐related adverse effects; only one study reported on expulsion with insufficient data for analysis. Secondary outcomes The LNG‐IUS may be associated with fewer hysterectomies (OR 0.26, 95% CI 0.15 to 0.46; I² = 19%; 4 RCTs, 452 participants; low‐quality evidence), fewer withdrawals from treatment due to hormone‐related adverse effects (OR 0.41, 95% CI 0.12 to 1.35; I² = 0%; 4 RCTs, 360 participants; low‐quality evidence) and improved patient satisfaction with treatment (OR 5.28, 95% CI 2.51 to 11.10; I² = 0%; 2 RCTs, 202 participants; very low‐quality evidence) compared to non‐intrauterine progestogens. The LNG‐IUS may be associated with more bleeding/spotting (OR 2.13, 95% CI 1.33 to 3.43; I² = 78%; 3 RCTs, 428 participants) and less nausea (OR 0.52, 95% CI 0.28 to 0.95; I² = 0%; 3 RCTs, 428 participants) compared to non‐intrauterine progestogens. Data from single trials for mood swings and fatigue had a similar direction of effect as for bleeding/spotting, nausea and weight gain. There was insufficient evidence to determine cost or resource use. LNG‐IUS versus no treatment Regression of endometrial hyperplasia: One study demonstrated that the LNG‐IUS is associated with regression of EH without atypia (OR 78.41, 95% CI 22.86 to 268.97; I² = 0%; 1 RCT, 190 participants; moderate‐quality evidence) compared with no treatment. This study did not report on any other review outcome. Authors' conclusions: There is moderate‐quality evidence that treatment with LNG‐IUS used for three to six months is probably more effective than non‐intrauterine progestogens at reversing EH in the short term (up to six months) and long term (up to two years). Adverse effects (device‐related and hormone‐related) were poorly and incompletely reported across studies. Very low quality to low‐quality evidence suggests the LNG‐IUS may reduce the risk of hysterectomy, and may be associated with more bleeding/spotting, less nausea, less withdrawal from treatment due to adverse effects, and increased satisfaction with treatment, compared to non‐intrauterine progestogens. There was insufficient evidence to reach conclusions regarding device‐related adverse effects, or cost or resource use.
Current Opinion in …, 2005
Background: This study was carried out to assess the clinical effectiveness of levonorgestrel releasing intrauterine device (LNG-IUS) in the treatment of menorrhagia due to either Dysfunctional Uterine Bleeding (DUB) or fibroid in Indian patients, and to assess patient satisfaction with this treatment modality. Methods: Sixty women with menorrhagia, 30 due to fibroid and 30 due to DUB, meeting inclusion criteria, received LNG-IUS and were prospectively followed up for 9 months with periodic clinical assessments and transvaginal ultrasounds. Patient satisfaction was assessed on a five-point scale. Results: One patient in DUB group was lost to follow-up. In DUB patients, the treatment failure rate was only 3.4% (1 out of 29 patients). The median PBAC score reduced by 95% at 9 months. Fibroid patients also had an equally impressive 97.7% reduction of PBAC score at 9 months, although the failure rate was higher (23.3%; 7 out of 30). Majority of patients were either "very satisfied" or "satisfied" with the treatment, although this percentage was more in DUB (82.8%) than in the fibroid group (66.7%). Haemoglobin and serum ferritin levels significantly increased in both groups. No major side effect was noted. Conclusions: LNG-IUS is an excellent treatment modality for patients of DUB, with good patient satisfaction. It is also a useful treatment option in non-submucosal small fibroids for the symptoms of menorrhagia, can reduce uterine volume and can help avoid hysterectomy, but there is no effect on fibroid volume. Majority of patients are satisfied, although satisfaction rates are less than in DUB patients.
Journal of Health & Biological Sciences, 2020
Relato de Caso: Paciente de 44 anos compareceu ao serviço de ginecologia para consulta de rotina. Relatou implante de dispositivo intrauterino com liberação de levonorgestrel (DIU-LNG) há cinco anos. Durante o exame físico, o fio do dispositivo não foi visualizado. À histeroscopia, para remoção do dispositivo, não foram evidenciadas alterações na cavidade endometrial. Material foi, então, colhido para biópsia. O estudo histopatológico evidenciou um endométrio com estroma expandido por pseudodecidualização e alterações mucoides, formando pequenos aglomerados de mucina, também se apresentando com endentações polipoides, vasos ectásicos, focos de células linfoides e depósitos de sais de cálcio. A presença de DIU-LNG na cavidade uterina causa uma série de alterações histopatológicas e funcionais no endométrio, as quais não são relacionadas, exclusivamente, ao efeito contraceptivo do dispositivo. Conclusão: Com o aumento da utilização desse método anticoncepcional, o conhecimento das alterações provocadas pelo seu uso se torna cada vez mais relevante para avaliação de sua eficácia e segurança em longo prazo.
Combined Oral Contraceptive Therapy in Women with Posterior Deep Infiltrating Endometriosis
Journal of Minimally Invasive Gynecology, 2011
Study Objective: To estimate the effect of combined oral contraceptives (COCs) in women with deep infiltrating endometriosis. Design: Retrospective study (Canadian Task Force classification II-2). Setting: Tertiary care university hospital. Patients: One hundred six women with uncomplicated posterior deep infiltrating endometriosis scheduled to undergo laparoscopic surgery between November 2004 and November 2009. Interventions: During the waiting-list time, between surgical scheduling and laparoscopic intervention (preoperative period), 75 patients received cyclic COCs (users), and 31 received no hormone therapy (COC nonusers). Measurements and Main Results: Patients had undergone 2 clinical examinations, at surgical scheduling and immediately before surgery. Presence and intensity of dysmenorrhea, dyspareunia, chronic pelvic pain, and dyschezia were evaluated using a 10-point visual analog scale (VAS) (primary outcome). In both examinations, patients underwent transvaginal ultrasonography to evaluate localization and mean diameter of endometriotic nodules. Quality of life was evaluated using the Short Form-36 (SF-36) score. Mean (SD) nodule diameter at the beginning and end of the preoperative period in COC users was, respectively, 24.81 (15.13) mm and 26.66 (15.5) mm (p 5 .09), and in the nonuser group was, respectively, 23.09 (11.11) mm and 30.89 (19.1) mm (p 5 .007). In COC users, VAS scores for dysmenorrhea, dyspareunia, chronic pelvic pain, and dyschezia did not vary significantly during the preoperative period (p 5 .90, p 5 .55, p 5 .15, and p 5 .17, respectively). In nonusers, VAS scores for dysmenorrhea and dyspareunia were significantly higher at the second examination than at the first examination (p 5 .002 and p 5 .005, respectively), whereas scores for chronic pelvic pain and dyschezia did not vary during the preoperative period (p 5 .88 and p 5 .16, respectively). The Short Form-36 total score did not vary significantly during the preoperative period in either the COC user group (p 5 .82) or the nonusers group (p 5 .76). Conclusions: Combined oral contraceptive therapy can have a role in restraining the progression of dysmenorrhea and dyspareunia and the growth of deep endometriotic nodules.
Amenorrhea rates and predictors during 1 year of levonorgestrel 52 mg intrauterine system use
Contraception, 2017
The objective was to evaluate amenorrhea patterns and predictors of amenorrhea during the first year after levonorgestrel 52 mg intrauterine system (IUS) placement. This cohort analysis includes 1714 nulliparous and parous women who received a Liletta® levonorgestrel 52 mg IUS in a multicenter trial to evaluate efficacy and safety for up to 8 years. Participants maintained a daily diary with bleeding information. We assessed bleeding patterns in 90-day intervals; amenorrhea was defined as no bleeding or spotting in the preceding 90 days. We employed multivariable regression to identify predictors of amenorrhea at 12 months. The predictor analysis only included women not using a levonorgestrel IUS in the month prior to study enrollment. In the month before enrollment, 148 and 1566 women, respectively, had used and not used a levonorgestrel IUS. Prior users averaged 50±19 months of use before IUS placement; 38.4% of these women reported amenorrhea at 12 months. Amenorrhea rates for no...
The levonorgestrel-releasing intrauterine system and endometriosis staging
Fertility and Sterility, 2007
Objective: To undertake an economic evaluation alongside the largest randomised controlled trial comparing Levonorgestrel-releasing intrauterine device ('LNG-IUS') and usual medical treatment for women with menorrhagia in primary care; and compare the cost-effectiveness findings using two alternative measures of quality of life.