Levonorgestrel-releasing Intrauterine System Insertion Research Articles

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.

Evaluation of a Levonorgestrel-Releasing Intrauterine System for Treating Endometrial Hyperplasia in Patients with Polycystic Ovary Syndrome

Objective: To evaluate the use of a levonorgestrel-releasing intrauterine system (LNG-IUS) for treating endometrial hyperplasia in patients with polycystic ovary syndrome (PCOS). Methods: LNG-IUSs were inserted in 60 PCOS patients with simple (40 cases), irregular (12 cases), or complex (8 cases) endometrial hyperplasia. Follow-ups were performed at 3, 6, 12, and 24 months after insertion. At each time point, changes in menstruation, hemoglobin level, and endometrial thickness and pathology were recorded. Menstrual changes were assessed with the Pictorial Blood Assessment Chart. Hemoglobin levels were measured by the Blood Routine Test. Endometrial thickness was determined by transvaginal ultrasound. Endometrial pathology was defined as simple, irregular, or complex endometrial hyperplasia by a pathologist after curettage. Outcomes at each time point were compared to baseline (pre-insertion) measurements by Student's t test or ANOVA (for multiple comparisons) with the post hoc Dunnett's test. Differences with a p < 0.05 were considered statistically significant. Results: At all time points after LNG-IUS insertion and in all patients, menstrual blood loss was decreased and hemoglobin level was increased significantly compared to pre-insertion levels. The endometrial thickness was significantly reduced in all groups after 12 months. Most patients showed transformation of the endometrial pathology, with complete disappearance of simple and irregular cases of endometrial hyperplasia and a decreased number of complex endometrial hyperplasia cases. Conclusions: LNG-IUS is an effective, safe, nonsurgical, and atraumatic approach with few side effects for the treatment of endometrial hyperplasia in patients with PCOS.

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.

Malposition and expulsion of the levonorgestrel intrauterine system among women with inherited bleeding disorders

The levonorgestrel-releasing intrauterine system (LNG-IUS) is indicated for the management of menorrhagia and for contraception. The LNG-IUS is effective at reducing menstrual bleeding and improving haemoglobin among women with bleeding disorders. Expulsion rates for the LNG-IUS among normal women are reported to be approximately 5-10%. The aim of this study was to examine the malposition and expulsion rates of the LNG-IUS among women with inherited bleeding disorders. We conducted a retrospective study of women with an inherited bleeding disorder in Kingston, Canada treated with an LNG-IUS between May 2005 and June 2012. The primary outcome was a combined endpoint of expulsion and/or malposition. Predetermined secondary outcomes were patient satisfaction and changes in haemoglobin and ferritin levels. The median age of the women at the time of LNG-IUS insertion was 31 years (range 18-43, mean 32.1 years). The most common diagnosis was type 1 VWD (12/20, 60%). There were three LNG-IUS expulsions and two episodes of device malposition resulting in removal [5/20 (25.0%), 95% CI 11.2-46.9%]. An additional five women had their device removed prematurely. The overall proportion of devices resulting in discontinuation in this population was 10/20 (50.0%, 95% CI 29.9-70.1%). In this retrospective study, a significant proportion of women with an inherited bleeding disorder had an LGN-IUS removed due to poor patient satisfaction, malposition, or expulsion. Further studies into the causes of higher complication rates and interventions such as premedication or prolonged treatment with antifibrinolytic agents targeted at improving outcomes in this population are required.

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.

Efficacy of Levonorgestrel-Releasing Intrauterine System Versus Oral Progestins in Treatment of Simple Endometrial Hyperplasia Without Atypia

To evaluate the efficacy of 3 progestin treatment regimens in the management of simple endometrial hyperplasia without cytological atypia in premenopausal women. Prospective randomized comparative study. The study included 90 premenopausal women with histological diagnosis of simple endometrial hyperplasia (EH) without atypia, during the period from January 2010 to March 2012, at TAIBA Hospital in Kuwait. Patients were randomly allocated to 3 groups of 30 patients each receiving medroxyprogesterone acetate (MPA, 10 mg/d; group I), norethisterone (NET, 15 mg/d; group II) for 10 days per cycle, or insertion of levonorgestrel-releasing intrauterine system (LNG-IUS; group III). Patients were reevaluated after 3 months of treatment. Patients with regression and persistence were offered the same medication they were using for another 3 months. The primary outcome of the study was the proportion of patients requiring further treatment for another 3 months. Patients in the LNG-IUS group showed the highest resolution rate (66.67%). Patients in MPA group had a resolution rate of 36.66% where the resolution rate was 40% in patients of NET group. The patients having LNG-IUS showed a regression rate of 33.3%, whereas patients receiving MPA and NET showed a regression rate of 60% and 56.67%, respectively. There was a statistically significant difference between the 3 groups regarding the proportion of patients requiring further treatment for another 3 months (χ(2) = 6.501; P = .0387). The LNG-IUS appears to represent an effective superior convenient treatment option for simple EH without atypia.

Endothelial function in women using levonorgestrel-releasing intrauterine system (LNG-IUS)

BackgroundOral levonorgestrel has been linked to increased cardiovascular risk, but currently, no information is available on the effect of the levonorgestrel-releasing intrauterine system (LNG-IUS) on endothelial dysfunction. The objective of this study was to assess endothelial function in LNG-IUS users. Study DesignSixty women underwent insertion of either an LNG-IUS (n=30) as study group or Copper-T intrauterine contraceptive device (TCu 380A intrauterine device) as control group (n=30). In the midluteal phase of menstrual cycle, endothelium-dependent flow-mediated dilatation (FMD) and endothelium-independent dilatation of brachial artery were studied before and after 3, 6 and 12 months of device insertion. We also assessed the correlation of FMD and serum concentrations of estradiol (E2), progesterone (P) and LNG. ResultsWith LNG-IUS, there was a nonsignificant decrease in mean FMD of brachial artery (p>.05) compared with the control group at different time points of the study. Before LNG-IUS, reactive hyperemia caused an 8.3%±1.3% increase in brachial artery diameter compared with 7.1%±1.1%, 7.4%±0.9% and 7.5%±0.9% after 3, 6 and 12 months of LNG-IUS (p>.05). The mean±SD LNG plasma levels at 3, 6 and 12 months of LNG-IUS application were 228±87, 204±94 and 191±79 pg/mL, respectively. E2 levels were comparable in women of both studied groups. Mean P levels were significantly lower after LNG-IUS insertion compared with before device insertion and with the control group (p<.05) at all study visits. No correlation was found between LNG levels and FMD. ConclusionsA nonsignificant change detected in endothelial function in LNG-IUS indicates that it has no increased cardiovascular risk.

Rates of Malposition and Expulsion of the Levonorgestrel-Releasing Intrauterine System Among Women with Inherited Bleeding Disorders

Abstract 3367 Introduction:Menorrhagia, or excessive menstrual bleeding (EMB), is defined as menstrual blood loss of greater than or equal to 80 ml per menstrual cycle1,2. EMB is an important public health problem affecting as many as 10–15% of pre-menopausal women3 and is a common presenting symptom in women referred to a gynecologist4,5. Although there are many etiologies of EMB, inherited bleeding disorders may be identified in as many as 10–20% of women with EMB6,7. The levonorgestrel-releasing intrauterine system (LNG-IUS) is an intrauterine device that secretes 20 mcg of levonorgestrel per day and is indicated for contraception and for the treatment of heavy menstrual bleeding8. There have been limited data for the use of the LNG-IUS among women with inherited bleeding disorders and expulsion and malposition rates are not well known. Expulsion occurs in approximately 5–10% of women without an inherited bleeding disorder9,10. The purpose of this study is to examine the proportion of levonorgestrel-releasing intrauterine systems resulting in expulsion or malposition among women with inherited bleeding disorders. Methods:Women with an inherited bleeding disorder were retrospectively identified from the records of the Women and Bleeding Disorders clinic at a tertiary care hospital in Kingston, Canada. Women were included if they were seen for EMB and treated with an LNG-IUS between May 2005 and June 2012. All LNG-IUS insertions during this time were performed by one of 2 gynecologists experienced in LNG-IUS insertion. The primary outcome was a combined endpoint of expulsion and/or malposition. Expulsion or malposition was suspected if LNG-IUS strings were not apparent on direct visualization, if the LNG-IUS was visible at the cervix os, or if the ongoing patient-related symptoms or concerns suggested possible malposition. Suspected expulsion and malposition were confirmed by endovaginal ultrasound. Results:108 women were seen in the Kingston Women and Bleeding Disorders clinic between May 2005 and June 2012. During this time, there were 23 LNG-IUS inserted in 20 women for the management of EMB. Follow-up was complete for 19/23 LNG-IUS insertions. The median age was 31 years (range 18 to 43). The most common diagnosis in the study population was type 1 Von Willebrand disease (VWD) (13/20, 65%). While there was no pre-medication used in the large majority of cases, 2 patients received treatment at the time of insertion: 1 with tranexamic acid (type 1 VWD) and 1 with recombinant factor VIII (hemophilia A carrier). During this study period, there were 5 episodes of LNG-IUS expulsion or device malposition resulting in removal [5/19 (26.3%), 95% CI 11.8% to 48.8%]. An additional 5 women had their device removed for other reasons: 1 due to pain, and 4 due to failure of the LNG-IUS to satisfactorily reduce menstrual bleeding. The proportion of devices requiring removal in this population was 10/19 (52.6%, 95% CI 31.7% to 71.7%). The median time to device removal was 218 days (range 30 to 636). Among women whose LNG-IUS remained in proper position there was a significant increase in hemoglobin concentration associated with LNG-IUS insertion [122 g/L (SD 11.9) vs.129.5 g/L (SD 8.5), p=0.04, paired sample t-test]. Conclusions:In this retrospective study, over half (52.6%) of women with an inherited bleeding disorder had an LGN-IUS removed due to poor patient satisfaction, malposition, or expulsion. In this group of women with bleeding disorders (and no premedication at the time of the insertion), the proportion of LNG-IUS resulting in expulsion or malposition was 26.3%, which is higher than that reported among women without a bleeding disorder. Women with inherited bleeding disorders may be at increased risk of expulsion due to heavy menstrual blood flow and/or uterine contractions. Further study into the causes of higher complication rates and interventions such as premedication or prolonged treatment with anti-fibrinolytic agents targeted at improving outcomes in this population is required. Disclosures:James:CSL-Behring, Baxter, Bayer: Honoraria, Research Funding.

Temporal changes in cervical mucus after insertion of the levonorgestrel-releasing intrauterine system

BackgroundThe major contraceptive action of the levonorgestrel-releasing intrauterine system (LNG-IUS) is cervical mucus (CM) thickening, which prevents sperm penetration. No study to date has examined the temporal relationship between the insertion of the LNG-IUS and changes in CM quality and sperm penetration. Study DesignParticipants were enrolled in a clinically descriptive study to compare the quality of CM and three parameters of sperm penetration prior to insertion of the LNG-IUS and on Days 1, 3 and 5 after insertion. Measurements of estradiol, progesterone and levonorgestrel (LNG) in serum and LNG in CM were also carried out at these times. CM was analyzed using the World Health Organization CM grading criteria. Sperm penetration was determined using an in vitro sperm–CM penetration test. ResultsAll 10 participants underwent LNG-IUS insertion during midcycle when CM quality was good and sperm penetration was excellent. On Day 1 after LNG-IUS insertion, the majority of participants demonstrated poor CM quality and poor sperm penetration. On Day 3, all participants had poor CM quality, and all but one subject had poor sperm penetration. By Day 5, all participants had poor CM quality and poor sperm penetration. LNG levels in CM peaked on the day after LNG-IUS insertion. ConclusionSignificant changes in quality of CM and sperm penetration were observed shortly after LNG-IUS insertion; however, CM can remain penetrable for up to 5 days when the LNG-IUS is inserted midcycle.

Treatment with Medroxyprogesterone Acetate Plus Levonorgestrel-releasing Intrauterine System for Early-stage Endometrial Cancer in Young Women: Single-arm, Prospective Multicenter Study: Korean Gynecologic Oncology Group Study (KGOG2009)

A prospective multicenter trial has been started in Korea to investigate the treatment efficacy of a levonorgestrel-releasing intrauterine system plus medroxyprogesterone acetate in young women with early-stage endometrial cancer. A number of studies have reported the effectiveness of hormonal therapy using systemic progestin in women clinically diagnosed with early endometrial adenocarcinoma at Stage IA, Grade 1, who want to maintain reproductive potential. In addition, several recent studies reported the use of a levonorgestrel-releasing intrauterine system to treat patients at a high risk of perioperative complications who cannot tolerate systemic progesterone because of its adverse effects. However, there has been no prospective multicenter trial that investigated the effectiveness of treatment with systemic progesterone in combination with intrauterine progesterone in young women with endometrial cancer. Young patients with histologically confirmed Grade 1 endometrioid adenocarcinoma that is presumably confined to the endometrium, who desired to preserve their fertility potential, undergo levonorgestrel-releasing intrauterine system insertion and are administered medroxyprogesterone acetate at a dosage of 500 mg/day concurrently. The follow-up and treatment response assessment were implemented at a 3-month interval with office endometrial aspiration biopsy with the levonorgestrel-releasing intrauterine system in place, and dilatation and curettage after removal of the levonorgestrel-releasing intrauterine system. The primary endpoint is the complete response rate. The secondary endpoint is to estimate the consistency of the results of the office endometrial aspiration biopsy with the levonorgestrel-releasing intrauterine system in the uterus and a dilatation and curettage after removal of the levonorgestrel-releasing intrauterine system.

Resources and procedures in the treatment of heavy menstrual bleeding with the levonorgestrel-releasing intrauterine system (LNG-IUS) or hysterectomy in Brazil

BackgroundHeavy menstrual bleeding (HMB) is the most common complaint of women seeking gynecological care. Treatments included surgical or medical options including hysterectomy and the levonorgestrel-releasing intrauterine system (LNG-IUS) due to the profound suppression of endometrial growth that intrauterine LNG exerts which results in amenorrhea or in a reduction of blood loss. ObjectiveThe study was conducted to evaluate the resources and procedures involved in inserting an LNG-IUS compared to performing hysterectomy in women with HMB in a public sector hospital in Brazil. Study designTwo cohorts of women were studied: women who accepted an LNG-IUS (n=124) and matched women who underwent hysterectomy on the same day (n=122). We evaluate the number of procedures carried out in each group of women, including those performed before the decision was made to insert an LNG-IUS or to perform hysterectomy, the insertion of the device itself and the surgical procedure, in addition to the procedures and complications registered up to 1 year after LNG-IUS insertion or hysterectomy. ResultsAge and the duration of HMB were significantly lower in the LNG-IUS acceptors than women at the hysterectomy group. The numbers of gynecological consultations and Pap smears were similar in both groups; however, women in the hysterectomy group also underwent laboratory tests, ultrasonography, chest X-ray and electrocardiogram. In the hysterectomy group, the main complications were hemorrhage (six), bladder/bowel perforation (four), complications with anesthesia (one), ureteral reimplantation required (one) and abdominal pain (two). At 1 year, HMB was controlled in 83.1% of women in the LNG-IUS group, and 106 women continued with the device. ConclusionsBoth treatments were effective in HMB control. Fewer resources and complications were observed in LNG-IUS acceptors when compared to hysterectomy. The LNG-IUS represents a good strategy for reducing the number of hysterectomies and the resources required for women with HMB.

Changes in Bone Mineral Density of Users of the Levonorgestrel-releasing Intrauterine System

The aim of this study was to evaluate changes in bone mineral density (BMD) in patients using a levonorgestrel-releasing intrauterine system (LNG-IUS) or a TCu380A intrauterine device (IUD) after 2 years. The medical records of all patients who underwent LNG-IUS (n=38) or TCu380A IUD (n=26) insertion from May 2006 through December 2010 were reviewed. The patients were 40 to 45 years old at the time of insertion, had undergone a BMD examination of the femur and lumbar spine before the loop insertion, and had also received a follow-up BMD examination 2 years later. Patients were excluded if risk factors known to affect BMD were noted in their medical records. The 2 groups of patients were compared with regard to age, parity, body-mass index (BMI), and levels of osteocalcin and pyridinoline. Changes in BMI, osteocalcin, and pyridinoline after 2 years were also compared. The LNG-IUS and TCu380A IUD groups showed no differences in mean age, mean parity, mean BMI, preinsertion or postinsertion BMD values of the femur or lumbar spine, changes after 2 years in the BMD of the femur or lumbar spine, or changes after 2 years in osteocalcin or pyridinoline level (P>0.05). Women using the LNG-IUS for 2 years have changes in BMD and osteocalcin and pyridinoline levels similar to those of TCu380A IUD users. The use of the LNG-IUS for 2 years may have no adverse effect on BMD.

Ibuprofen prophylaxis for levonorgestrel-releasing intrauterine system insertion: a randomized controlled trial

BackgroundDespite the high efficacy of the levonorgestrel-releasing intrauterine system (LNG-IUS) in preventing pregnancy, uptake of the intrauterine devices remains low in the United States. Decreasing pain at the time of intrauterine device insertion may be one way to increase interest in this method of contraception. Study DesignWe conducted a double-blind, placebo-controlled trial, randomizing women to 800 mg ibuprofen or placebo 45 min prior to LNG-IUS insertion to determine effect of ibuprofen on the pain of LNG-IUS insertion. ResultsEighty-one women completed the study: 44 received ibuprofen, and 37 received placebo. Women in the ibuprofen and placebo groups had similar mean scores for anticipated pain (4.07 and 3.91, respectively; p=.79), pain with tenaculum placement (3.86 and 3.81, respectively; p=.90) and pain with insertion (3.69 and 3.34, respectively; p=.91). ConclusionAdministration of ibuprofen prophylaxis for LNG-IUS insertion does not decrease pain at the time of insertion.

Efficacy of the levonorgestrel-releasing intrauterine system in uterine leiomyoma

Objective To evaluate the efficacy of the levonorgestrel-releasing intrauterine system (LNG-IUS) in reducing menstrual blood loss (MBL) in myoma-related menorrhagia and to assess the effect of the LNG-IUS on uterine and leiomyoma volume. Methods A prospective comparative study investigated the effect of LNG-IUS use in women with myoma-related menorrhagia (n = 54) and women with idiopathic menorrhagia (n = 50). The outcome was assessed in terms of reductions in MBL and in myoma and uterine volume. Results Within 1 month of LNG-IUS insertion, the Pictorial Blood Loss Assessment Chart score in the myoma group fell by 86.8% ( P < 0.0001). At 3, 12, 24, 36, and 48 months, the MBL was reduced by 92.1%, 97.4%, 97.4%, 99.5%, and 99.5%, respectively, similar to the effect seen in the idiopathic menorrhagia group. The mean uterine volume was significantly reduced in both groups, but the reduction was greater in the group with leiomyomas (idiopathic menorrhagia, P = 0.038; myoma-related menorrhagia, P = 0.012). There was no statistically significant reduction in the myoma volume ( P = 0.409). Conclusion Use of the LNG-IUS appears to lead to a significant reduction in the uterine volume of women with menorrhagia, as well as reducing the MBL in women with uterine leiomyomas.

One-year of follow-up of levonorgestrel-releasing intrauterine system use in patients with hemostatic disorders with and without anticoagulant therapy

The progestogens-only contraceptives methods seem not to impair blood coagulation. However, it is not known their effects in women with thrombophilia and/or previous venous thrombosis with or without anticoagulant therapy. Thus, our objective was to compare the effects of the levonorgestrel-releasing intrauterine system (LNG-IUS) on clinical parameters and complete blood count in women with hemostatic disorders with and without anticoagulant therapy. Prospective study. This study inclued 30 women between 18 to 40 years-old with thrombophilia and/or previous venous thrombosis. These women were divided into 2 groups: with anticoagulant therapy (ACO, n = 16) and without anticoagulant therapy (n = 14). All these women were selected in a planning family program. The variables analysed were blood pressure (BP), body mass index (BMI), complete blood count (CBC). These variables were analysed before, after 6 and 12 months of LNG-IUS insertion. The bleeding patterns in each group were also analysed. ANOVA with Tukey post-test was used for statistical analysis. There was no significant difference between the groups in term of age, BMI, BP and CBC. The bleeding patttern did not differ between the groups and amenorrhoea/infrequent bleeding were the most common patterns in both groups. The use of LNG-IUS has similar effects in clinical parameters and blood count in women with hemostatic disorders with and without anticoagulant therapy in 12 months of follow-up.

Ease of insertion and clinical performance of the levonorgestrel-releasing intrauterine system in nulligravidas

Background Despite the high contraceptive efficacy and the additional noncontraceptive benefits of the levonorgestrel-releasing intrauterine system (LNG-IUS), concerns persist with respect to its use in nulligravidas. The objective of this study was to evaluate the ease of insertion and clinical performance of the LNG-IUS in nulligravida women up to 1 year after insertion. Methods Two cohorts were formed after LNG-IUS insertion, one consisting of 159 nulligravidas and the other of 477 parous women. Each nulligravida women was paired with three parous women who had an LNG-IUS inserted on the same day. Insertion was classified as easy or difficult, and when classified as difficult, the use of Hegar dilators and/or misoprostol and insertion failure were additional factors recorded. Results In almost 80% of cases, no difficulty was encountered during insertion, and dilators and misoprostol were seldom required; however, when necessary, dilator use was almost threefold higher in nulligravida women. Insertion failed in one nulligravida women and in two parous women. Contraception was the most common reason for insertion, although some of the women received the LNG-IUS for both contraceptive and therapeutic purposes, including heavy menstrual bleeding, hematologic diseases, warfarin use, endometriosis-associated pain and following kidney or liver transplantation. The clinical performance of the device showed zero pregnancy rate, expulsion rates of ∼4/100 women-year and 1-year continuation rate of over 90% in both groups. Conclusions The LNG-IUS is suitable for use by nulligravidas. It is simple to insert, and its clinical performance in nulligravidas is similar to that found in parous women.

The efficacy of the levonorgestrel-releasing intrauterine system in perimenopausal women with menorrhagia or dysmenorrhea

To evaluate the hysterectomy rates and the risk factors for hysterectomy during the first 2years of use of a levonorgestrel-releasing intrauterine system (LNG-IUS) in perimenopausal women who had complaints of either menorrhagia or dysmenorrhea. One hundred ninety-two women over 40years old were retrospectively analyzed for a 2-year follow-up period. The changes in the amount and duration of bleeding and the pain scores were checked at 3, 6, 12 and 24months. Twenty-six (13.5%) women failed with LNG-IUS treatment and they received hysterectomy. Age, parity, the type of diseases, the amount of menstrual bleeding, the mean duration of persisted menorrhagia and the severity of pain before treatment were not the factors affecting removal of the LNG-IUS and undergoing hysterectomy. However, the pain score of the third month and the amount of bleeding on the sixth month were the factors affecting undergoing hysterectomy (P<0.05). When hysterectomy was performed, the average duration from LNG-IUS insertion to hysterectomy was 8.9months. The participants who persisted with the LNG-IUS treatment for 24months showed a success rate of 80.7%. LNG-IUS is an effective device for the treatment of perimenopausal women who have complaints of either menorrhagia or dysmenorrhea. Insufficient reduction of pain score during the first 3months and menstrual blood loss during the first 6months after insertion of the LNG-IUS were important factors that affected undergoing hysterectomy.

Length of time after insertion of the levonorgestrel-releasing intrauterine system for it to significantly alter cervical mucus quality and sperm penetration

OBJECTIVE: To compare the qualities of cervical mucus (CM) and three parameters of sperm penetration in CM of subjects prior to insertion of levonorgestrel-releasing intrauterine system (LNG-IUS) and at 1, 3 and 5 days after insertion using WHO cervical mucus grading criteria and an in-vitro sperm penetration test (SCMPT). DESIGN: Clinically descriptive. MATERIALS AND METHODS: Twenty-five ovulatory women who desire LNG-IUS for contraception are being enrolled for participation in this study. LNG-IUS is inserted when the cervical mucus grading score (CMGS) first reaches 10. CM evaluation and in-vitro SCMPT are performed just prior to LNG-IUS insertion and on post-insertion days 1, 3 and 5. RESULTS: To date six women have completed the study. The LNG-IUS was inserted on cycle day 10 in one subject, day 12 in four subjects and day 14 in one subject when all subjects' CM was of good quality and had good sperm penetration meter scores (SPMS). There were significant decreases in the median SPMS and median CMGS among CM samples obtained just prior to LNG-IUS placement, and those obtained days 1, 3 and 5 after insertion. CONCLUSION: When the LNG-IUS was inserted at the time of maximum CM production, CM was of poor quality with poor sperm penetration by day 1 after insertion of LNG-IUS in 5 of 6 subjects and by day 3 in all six subjects and remained poor during post-insertion day 5. It appears the LNG-IUS becomes contraceptively effective 3 days after insertion, possibly earlier, however, more subjects are needed to clarify this issue. These preliminary data suggest back up contraception is not needed for more than 3 days after LNG-IUS insertion.

Levonorgestrel-releasing intrauterine system (LNG-IUS) as an effective treatment option for endometrial hyperplasia: a 15-year follow-up study

The levonorgestrel-releasing intrauterine system may represent an effective treatment option in >85% of endometrial hyperplasia cases, but histologic regression during and/or at the end of treatment does not assure stable recovery. We recommend periodic endometrial samplings for at least the first 2 years of follow-up and long-term clinical surveillance thereafter.

Ibuprofen prophylaxis for levonorgestrel-releasing intrauterine system insertion: a randomized controlled trial

Ibuprofen prophylaxis for levonorgestrel-releasing intrauterine system insertion: a randomized controlled trial