Levonorgestrel-releasing Intrauterine System In Women Research Articles

The impact of self-administered vaginal isonicotinic acid hydrazide (INH) administration 12 hours prior to levonorgestrel-releasing intrauterine system in women delivered only by elective cesarean section: A randomized double blinded clinical trial

The impact of self-administered vaginal isonicotinic acid hydrazide (INH) administration 12 hours prior to levonorgestrel-releasing intrauterine system in women delivered only by elective cesarean section: A randomized double blinded clinical trial

Oncological and reproductive outcomes for gonadotropin-releasing hormone agonist combined with aromatase inhibitors or levonorgestrel-releasing intra-uterine system in women with endometrial cancer or atypical endometrial hyperplasia

ObjectiveTo evaluate the efficacy and safety of gonadotropin-releasing hormone agonist (GnRHa) combined with a levonorgestrel-releasing intrauterine device (LNG-IUD) or aromatase inhibitor (letrozole) in women with endometrial carcinoma or atypical endometrial...

Evaluation of the efficacy of levonorgestrel intrauterine system in the management of heavy menstrual bleeding: An analytical observational study

Background: Heavy menstrual bleeding (HMB) poses threat to the quality of life among women. To prevent HMB, the levonorgestrel-releasing intrauterine system (LNG-IUS) is a well-known nonsurgical, long-performing, and alternative method. Objectives: The objective of this study was to determine the efficacy of LNG-IUS in women with HMB through an analytical observational study. Materials and Methods: This study was performed among 60 patients who visited the gynecology and obstetrics outpatient department (OPD) at the Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital (IPGMER and SSKMH), Kolkata, West Bengal, India from May 2019 to April 2020 due to HMB. The mean demographic and clinical profiles were evaluated, and comparative analysis was performed for hemoglobin (Hb), spotting, pain, and endometrial thickness on day 0 and follow-up 3 months, 6 months, and 12 months. Results: The mean age of patients was 37.77 ± 4.58 years was obtained. The Hb level was significantly (P < .001) increased, whereas pictorial blood loss assessment chart (PBAC) score, endometrial thickness, spotting, and pain were significantly (P < .01 and P < .001) reduced. The majority of patients had pallor, but the rates of spontaneous expulsion and hysterectomy were observed lower after using LNG-IUS among studied patients. Conclusion: the usage of LNG-IUS is potential in the treatment of HMB in women, which may lead to a better quality of life. This can be the alternative to hysterectomy and oral pills for long-term use. It is suggested in a future study with larger sample size and multicentric approach to minimize hospital biasness.

The Combined Use of Endometrial Ablation or Resection and Levonorgestrel-Releasing Intrauterine System in Women With Heavy Menstrual Bleeding: A Systematic Review

(Abstracted from Acta Obstet Gynecol Scand 2021;100:1779–1787) Heavy menstrual bleeding (HMB) affects approximately 10% to 30% of women of reproductive age and is often treated conservatively with insertion of a levonorgestrel-releasing intrauterine system (LNG-IUS) or endometrial ablation/resection (EA). The LNG-IUS induces atrophy of endometrial tissue, whereas EA is a minimally invasive, uterus-preserving procedure that destroys endometrial tissue and superficial myometrium.

Vaginal Dinoprostone Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System in Women With no Previous Vaginal Delivery

Vaginal Dinoprostone Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System in Women With no Previous Vaginal Delivery

Effect of pretreatment with a levonorgestrel-releasing intrauterine system on IVF and vitrified-warmed embryo transfer outcomes in women with adenomyosis.

Does the use of a levonorgestrel-releasing intrauterine system (LNG-IUS) improve the ongoing pregnancy rate of vitrified-warmed embryo transfer in women with adenomyosis undergoing IVF? This retrospective study included 358 women with adenomyosis undergoing IVF. Of these, 134 women were enrolled in the LNG-IUS group and another 224 women were in the control group. All women were screened for adenomyosis by transvaginal ultrasound and magnetic resonance imaging (MRI). There was no significant difference in the ages of women, FSH, cause of infertility, body mass index, total dose of gonadotrophin used and number of oocytes collected between the two groups. All comparisons performed were between patients undergoing vitrified-warmed embryo transfer. Statistical differences were found in the ongoing pregnancy rates (41.8% vs 29.5%, P = 0.017) between the LNG-IUS group and control group. Logistic regression analysis showed that the odds ratio (OR) of ongoing pregnancy was significantly increased with LNG-IUS usage (adjusted OR = 1.628, 95% confidence interval 1.011-2.622). Also, differences were found in implantation rates (32.1% vs 22.1%, P = 0.005) and clinical pregnancy rates (44% versus 33.5%, P=0.045) between the LNG-IUS group and control group. The results of this study offer some support for evaluating the effect of pretreatment with LNG-IUS in women with adenomyosis in future randomized controlled trials.

Safety and efficacy of a 52-mg levonorgestrel-releasing intrauterine system in women with cardiovascular disease.

We sought to examine the safety and efficacy of a 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS), and to evaluate the changes in biomarkers of infection, anemia and cardiovascular conditions after LNG-IUS insertion in women with cardiovascular disease. We prospectively followed women with a cardiovascular disease in whom a 52-mg LNG-IUS was inserted between 2009 and 2015. The primary outcome was the frequency of cardiovascular and gynecologic side effects due to the LNG-IUS over the year after LNG-IUS insertion. The secondary outcomes were the changes in menstrual blood loss and biomarkers, e.g., white blood cell count and the levels of C-reactive protein, hemoglobin and brain natriuretic peptide. We also evaluated the 24-month continuation rate of LNG-IUS. A total of 34 women were prospectively followed-up, including two women with pulmonary hypertension. No cardiovascular side effects were identified during the 1 year after LNG-IUS insertion, other than one case of mild vasovagal reaction at insertion. Neither the white blood cell count nor the C-reactive protein value increased after LNG-IUS insertion. The menstrual blood loss was decreased in most subjects and the median hemoglobin levels increased significantly within 1 year after insertion (P < 0.001 and P = 0.002). Moreover, brain natriuretic peptide levels tended to decrease in correspondence with the hemoglobin elevation (P = 0.074). The 24-month LNG-IUS continuation rate was 97% (95% confidence interval 85-100). No clinically significant cardiovascular event was identified during the 1 year after 52-mg LNG-IUS insertion among women with cardiovascular disease. The 52-mg LNG-IUS may have specific favorable effects by decreasing the risk of iron deficiency anemia in these women.

Effect of intracervical anesthesia on pain associated with the insertion of the levonorgestrel-releasing intrauterine system in women without previous vaginal delivery: a RCT

Is the pain associated with levonorgestrel-releasing intrauterine system (LNG-IUS) insertion reduced by intracervical anesthesia in women without previous vaginal birth? Intracervical anesthesia was not associated with reduced pain in women without previous vaginal birth. The pain associated with the insertion of intrauterine contraceptives (IUCs) is a limiting factor for the use of these contraceptives by some women. No prophylactic pharmacological intervention has proven efficacy in relieving pain during or after the insertion of IUCs. However, previous studies included women with previous vaginal delivery, and injectable intracervical anesthesia was not evaluated in any of these studies. This was a randomized, open, parallel-group clinical trial that evaluated 100 women without previous vaginal delivery who wished to use the LNG-IUS for the first time. These women were evaluated immediately after LNG-IUS insertion and then 2 h and 6 h later. The 100 women were randomized into two groups: (i) use of a non-steroidal anti-inflammatory drug (NSAID) (ibuprofen, 400 mg) 1 h prior to LNG-IUS insertion; or (ii) 2% lidocaine intracervical injection 5 min prior to LNG-IUS insertion. The women were evaluated immediately after LNG-IUS insertion and then 2 h and 6 h after insertion. Two pain scales were used (the visual analogue scale and the facial pain scale) in addition to assessing the ease of insertion (as rated by the provider) and the level of discomfort during the procedure (as rated by the patient). Multivariate logistic regression was performed to analyze the predictors associated with moderate/severe pain. The pain and discomfort associated with LNG-IUS insertion, and the ease of insertion of the LNG-IUS did not differ between the groups. Nulliparity was more associated with moderate/severe pain [adjusted odds ratio (OR): 3.1 (95% confidence interval (CI): 1.3-7.80]. Injectable intracervical anesthesia use reduced the risk of moderate/severe pain by 40% [adjusted OR: 0.6 (95% CI: 0.2-1.4)]. The difference between the mean pain score in the intracervical anesthesia group and the NSAID group was <10%; thus, the effect size of the intervention was not significant. Intracervical anesthesia was compared with an oral medication in this study. Intracervical injection of a saline solution or even a dry needling as the placebo for a double-blind study could be a more adequate control; however, this approach was not a protocol approved by the institutional review board. Considering that the majority of the insertions were easy (>80% in both groups), the results may not be extrapolated to difficult insertions with moderate/severe pain where local anesthesia may have a role. The findings can be generalized to most insertions in nulliparous women or in those without a previous vaginal delivery. There is currently no evidence to recommend the routine use of prophylactic intracervical anesthesia prior to LNG-IUS insertion; there is no evidence that this treatment reduces insertion-related pain. RAF and CSV give occasional lectures for Bayer Healthcare. This study received funding from the National Institute of Hormones and Women's Health, National Council for Scientific and Technological Development (CNPq). NCT02155166.

Prophylactic Use of Levonorgestrel-Releasing Intrauterine System in Women With Breast Cancer Treated With Tamoxifen

Prophylactic Use of Levonorgestrel-Releasing Intrauterine System in Women With Breast Cancer Treated With Tamoxifen

Oral anticoagulant therapy does not modify the bleeding pattern associated with the levonorgestrel-releasing intrauterine system in women with thrombophilia and/or a history of thrombosis

BackgroundProgestogen-only contraceptives (POCs) are suitable for women with thrombophilia and/or a history of venous thromboembolism (VTE). Several of these women, however, use oral anticoagulant therapy (OAT), which can impair the bleeding pattern associated with POC use. We evaluated the effects of OAT use on the bleeding pattern associated with the levonorgestrel-releasing intrauterine system (LNG-IUS) in women with thrombophilia and/or a history of VTE. Study DesignThis prospective cohort study followed two groups of women, all of whom were thrombophilic and/or had a history of VTE: OAT users and nonusers. Bleeding patterns, blood pressure, body mass index (BMI), weight, complete blood count and waist circumference were compared between the two groups before and 6 and 12 months after LNG-IUS insertion. ResultsThe patient cohort consisted of 33 women aged 18 to 45 years old, including 16 OAT users and 17 nonusers. Body weight increased by 3.9% and BMI by 3.8% in OAT users 12 months after LNG-IUS insertion. Hemoglobin and hematocrit levels increased by approximately 10% in both groups. There was no difference between the groups in bleeding patterns, with amenorrhea being the most frequent pattern in both groups (41.2% each) 12 months after LNG-IUS insertion. OAT did not increase the frequency of prolonged and/or frequent bleeding. ConclusionOAT users and nonusers had similar bleeding patterns after insertion of the LNG-IUS. Hemoglobin and hematocrit levels increased in both groups.

Analysis of the levonorgestrel-releasing intrauterine system in women with endometriosis

To compare the efficacy, safety and other clinical benefits of the levonorgestrel-releasing intrauterine system (LNG-IUS) and gonadotropin-releasing hormone analogues (GnRH-a) in women with endometriosis. A systematic search was carried out using the Cochrane Central Register of Controlled Trials, PubMed, MEDLINE™ and EMBASE databases for all randomized controlled trials (RCTs) that evaluated the use of the LNG-IUS and GnRH-a in premenopausal women with endometriosis. Five RCTs studies were identified. A meta-analysis showed that, in women with endometriosis, both the LNG-IUS and GnRH-a reduced pain visual analogue scale scores (weighted mean difference [WMD] 0.03 [95% confidence interval [CI] -0.53, 0.59]), serum levels of CA125 (WMD -12.29 [95% CI -29.90, 3.32]), and American Society of Reproductive Medicine staging scores (WMD 1.10 [95% CI -27.98, 30.18]). Psychological and general wellbeing index scores were increased (WMD 1.50 [95% CI -6.19, 9.19]). Levels of low-density lipoprotein cholesterol were also significantly reduced in patients treated with the LNG-IUS (WMD 39.30 [95% CI 6.74, 71.86]). The LNG-IUS had clinical efficacy equivalent to that of GnRH-a but may have some clinical advantages over GnRH-a in the treatment of endometriosis-associated symptoms. These observations will require further verification in additional studies employing larger patient populations.

Prophylactic Use of Levonorgestrel-Releasing Intrauterine System in Women With Breast Cancer Treated With Tamoxifen

To estimate the rate of endometrial pathology with the prophylactic use of levonorgestrel-releasing intrauterine system in women with breast cancer treated with tamoxifen. This was a randomized contro-lled trial of 129 Chinese women who attended a university hospital in Hong Kong and required adjuvant tamoxifen for breast cancer after the completion of postoperative radiotherapy and chemotherapy. Women were randomized to treatment (prophylactic levonorgestrel-releasing intrauterine system insertion before the commencement of tamoxifen) or control group. The uterine cavity was examined by hysteroscopy and endometrial sampling before the commencement of tamoxifen and at 12, 24, 45, and 60 months afterward. Any endometrial polyps or submucosal fibroids were resected through hysteroscopy at each assessment and specimens were sent for histologic confirmation. A total of 94 women completed 5-year follow-up. There was no significant difference in the occurrence of submucosal fibroids (1 [1.8%] compared with 2 [3.4%]) and endometrial hyperplasia (both 0) in the treatment and control groups, respectively. Levonorgestrel-releasing intrauterine system significantly reduced de novo endometrial polyps (hazard ratio 0.19, 95% confidence interval 0.07-0.48) over the course of 5 years on an intention-to-treat basis. There was no statistically significant increase in breast cancer recurrence rate (10 [17.2%] compared with 6 [10.0%]) or cancer-related deaths (6 [10.3%] compared with 5 [8.3%]) in the treatment group, but the study was underpowered in this regard. Prophylactic levonorgestrel-releasing intrauterine system prevents de novo endometrial polyps in women using tamoxifen. However, its role in the prevention of endometrial hyperplasia and adenocarcinoma as well as its effect on risk of breast cancer recurrence remain uncertain. Chinese Clinical Trial Registry, http://www.chictr.org/en/, ChiCTR-TRC-09000625. I.

The Levonorgestrel-Releasing Intrauterine System in Heavy Menstrual Bleeding

Heavy menstrual bleeding (HMB) is a common problem in women of reproductive age and can cause irritation, inconvenience, self-consciousness and fear of social embarrassment. Our objective was to review and appraise literature identified from the MEDLINE and EMBASE databases to evaluate the clinical evidence and provide an update on the risks and benefits of using the levonorgestrel-releasing intrauterine system (LNG-IUS) in the treatment of HMB. The LNG-IUS consistently reduces menstrual blood loss (MBL) in women with HMB, including those with underlying uterine pathology or bleeding disorders. The available data suggest that it reduces MBL to a greater extent than other medical therapies, including combined oral contraceptives, oral progestogens (both short- or long-cycle regimens), tranexamic acid and oral mefenamic acid. In addition, the LNG-IUS and endometrial ablation appear to reduce MBL to a similar extent. The adverse effects reported with the LNG-IUS in women with HMB are similar to those typically observed in women using the system for contraception. Uterine perforations were not reported in any of the studies reviewed, but expulsion rates may be higher than in the general population of LNG-IUS users. Overall, the LNG-IUS has a positive effect on most quality-of-life domains, at least comparable to those achieved with hysterectomy or endometrial ablation, and is consistently a cost-effective option across a variety of countries and settings. In conclusion, the LNG-IUS is an effective treatment option for women with HMB, including those with underlying organic pathology or bleeding disorders.

Use of the levonorgestrel-releasing intrauterine system in women with hemostatic disorders

To evaluate the use of the levonorgestrel-releasing intrauterine system (LNG-IUS) in women with known hemostatic disorders and abnormal uterine bleeding. Retrospective case series. Tertiary medical center. Women with regular, heavy menstrual bleeding who have von Willebrand's disease and/or are receiving anticoagulation therapy for a thrombotic disorder. Levonorgestrel intrauterine system. Impact on menstrual bleeding and quality of life. Seven women with hemostatic disorders who had used the LNG-IUS were identified. All 7 women completed the survey. Median age was 38 years (range 28-48 years). Six women were white, 1 woman was black. Four women had von Willebrand's disease. Four women were using anticoagulation, 3 warfarin, and 2 aspirin. One woman had both von Willebrand's disease and was heterozygous for factor V Leiden. All 7 women had heavy menstrual bleeding. After placement of the LNG-IUS, a decrease in number of bleeding days was seen in 71% of subjects (5 of 7), with overall median days reduced from 9 to 3 days. One subject discontinued use of the LNG-IUS because she desired pregnancy. Two subjects (29%) had no benefit from the LNG-IUS. Quality of life improved after placement of the LNG-IUS. The LNG-IUS seems to be an effective treatment for heavy menses in women with hemostatic disorders. Providers should consider this option for women with hemostatic disorders because it is safe and simple to use.

Therapeutic use of levonorgestrel-releasing intrauterine system in women with menorrhagia: a pilot study

The objective of this study was to evaluate the efficacy and performance, for up to 1 year, of an intrauterine system releasing 20 μg/day of levonorgestrel (LNG-IUS, Mirena) in the treatment of women with menorrhagia. It was a descriptive, prospective, non-comparative study. A 20 μg/day LNG-releasing-IUS was inserted on any day during bleeding to 44 women (between 24 and 49 years of age) who presented with menorrhagia after medical therapies had failed. Menstrual patterns were assessed, and hemoglobin concentrations were measured before LNG-IUS was inserted and at 3, 6, 9, and 12 months of use. The most common bleeding pattern at 3 months after insertion was spotting, and after 6, 9, and 12 months the majority of women presented with amenorrhea or oligomenorrhea. Three women requested removal of the LNG-IUS because of spotting, and six women expelled it spontaneously. Hemoglobin levels were improved from 102 g/L to 123 and 128 g/L at 3 and 12 months, respectively, after insertion of the LNG-IUS (p < 0.01). At 12 months 79.5% of participants continued the use of LNG-IUS. In conclusion, LNG-IUS was an effective treatment for three out of four women with menorrhagia and could be an alternative treatment for women with menorrhagia who are either contraindicated for or refuse hysterectomy or endometrial ablation.