Assessment of menstrual blood loss in women with ideopathic menorrhagia using the frameless levonorgestrel-releasing intrauterine system

OBJECTIVE: This study was conducted to evaluate the effect of a "low-dose" levonorgestrel (LNG)-releasing intrauterine system (IUS) on the amount of menstrual blood loss (MBL) in women with ideopathic menorrhagia. METHODS: Menstrual blood loss was assessed with the visual assessment technique in 12 Belgian FibroPlant-LNG users with menorrhagia. In addition, ferritin levels were measured. RESULTS: The median MBL, evaluated by the visual scoring technique, decreased by more than 90%. The ferritin levels increased significantly during treatment with the levonorgestrel system. CONCLUSION: This study confirms previous MBL studies conducted with the FibroPlant-LNG IUS demonstrating the efficacy of the LNG-IUS to significantly reduce the amount of MBL in women with menorrhagia. The strong endometrial suppression is the principal mechanism explaining the effect on MBL. The therapeutic effect of this contraceptive method is highly desirable, particularly in women with heavy bleeding or anemia, as other treatment modalities are less effective, more costly, more invasive or inaccessible. The simple design characteristics and anchoring system account for minimizing the occurrence of complaints of pain and expulsion.     

Ease of insertion, contraceptive efficacy and safety of new T-shaped levonorgestrel-releasing intrauterine systems

OBJECTIVE: The objective of the study was to evaluate ease of insertion, contraceptive performance and safety, in parous and nulliparous women, of two new T-shaped levonorgestrel (LNG)-releasing intrauterine systems (LNG-IUS), Femilistrade mark (parous women) and Femilis Slim (nulliparous women), releasing 20 mug of LNG per day. An ancillary objective was to evaluate expulsion and user continuation. DESIGN AND METHODS: An open, prospective, noncomparative study (interim analysis). Two hundred thirty-five insertions were performed in fertile women seeking contraception. Of these, 143 (60.8%) parous women were fitted with Femilis and 92 (39.2%) nulliparous women were fitted with Femilis Slim. The LNG-IUS was inserted using a simplified push-in technique (without folding the cross-arms in the insertion tube). RESULTS: This paper is the first report with the Femilis LNG-IUS. The push-in technique of insertion was considered simple and safe. Insertion was reported "easy" in virtually all women (97.9%). Pain at insertion was absent in 24.7% and "mild" in 67.7% of women. With respect to pain, there were no statistical differences between the parous and nulliparous group. At the time of study analysis, the total number of women-months of use was 1769.7. Seventy-six women had the Femilis IUS in place for periods in excess of 1 year. The study was well followed up with lost to follow-up of only two women. No pregnancies were observed. There was one expulsion in the nulliparous and one in the parous group. Ten removals were performed for medical reasons (mainly bleeding and pain). One pelvic infection occurred in a nulliparous woman caused by Chlamydia trachomatis, which was resolved without removing the IUS. There were no other serious adverse events reported. Both Femilis and Femilis Slim were well tolerated, which resulted in a high continuation rate (94.04%). CONCLUSION: The Femilis LNG-IUS is an effective contraceptive and is easily inserted. The simple and safe insertion procedure could be an advantage for use by nonspecialist providers such as nurses, midwives, general practitioners, and for those not inserting intrauterine devices regularly. Femilis Slim could be an attractive long-term contraceptive option in young and adolescent women.     

Assessment of menstrual blood loss in Brazilian users of the frameless copper-releasing IUD with copper surface area of 330 mm2 and the frameless levonorgestrel-releasing intrauterine system

OBJECTIVE: This study was conducted to evaluate the effect of two types of IUDs on the amount of menstrual blood loss (MBL): the frameless copper-releasing intrauterine device (IUD) with copper surface area of 330 mm2 (GyneFix; Contrel Research, Ghent, Belgium) and the frameless levonorgestrel (LNG)-releasing intrauterine system (IUS) releasing 14 microg per day (FibroPlant-LNG; Contrel Research). Heavy and abnormal MBL is the main reason for discontinuation of intrauterine devices. METHODS: In 20 Brazilian women using GyneFix 330 and 32 using FibroPlant-LNG, respectively, MBL was measured by the quantitative alkaline hematin technique. In addition, ferritin levels were measured in GyneFix 330 and FibroPlant-LNG users. RESULTS: MBL with GyneFix 330, measured over a 24-month period, increased but was less when compared with TCu380A. Ferritin levels with GyneFix 330 were not affected in contrast with TCu380A. In FibroPlant-LNG users, mean MBL decreased by about 90% and ferritin levels increased significantly. CONCLUSIONS: The authors confirm earlier reports that, especially for women with low body iron stores and heavy menstrual bleeding, there is an order of preference for IUD use to minimize MBL. The choice should first be a progestin-releasing IUS, then a copper IUD, which has the least effect on menstrual bleeding, such as the frameless GyneFix IUD.     

Contraception and treatment in the perimenopause with a novel "frameless" intrauterine levonorgestrel-releasing drug delivery system: an extended pilot study

The objective of the study was to evaluate the contraceptive performance, acceptability, side effects, and adverse events of a novel "frameless" intrauterine drug delivery system (IUS), FibroPlant-levonorgestrel (LNG) releasing 14 microg of LNG/day, in perimenopausal women. An ancillary objective was to evaluate the effect of the new IUS on menstrual blood loss in women with or without fibroids.The study, consisting of 109 women, suggests that FibroPlant-LNG IUS is an effective contraceptive. No pregnancies occurred with the FibroPlant-LNG IUS. The total use-related discontinuation rate at 1 year is low (1.9) and results in a high rate of continuation of use (98.1). In addition, the FibroPlant-LNG IUS demonstrated a high level of effectiveness in reducing bleeding in women with excessive menstrual flow even when medium or large fibroids were present. However, an effect on the size of the fibroids could not be demonstrated.Patient satisfaction with the method is high, which is a prerequisite for continuance of the method, and may be linked with the advantageous design characteristics of the FibroPlant-LNG IUS, the virtual absence of hormonal side effects, and the low incidence of irregular bleeding and spotting even during the first 3 months after insertion of the FibroPlant IUS. Counseling remains important though to explain to women about the possible occurrence of changes in their menstrual pattern that may sometimes be annoying but harmless.It is concluded that many women over age 40 years could substantially benefit from the advantages of this intrauterine drug delivery technology which provides contraception and treatment of a possible associated condition such as menorrhagia. The treatment also creates the opportunity to pass through the transitional perimenopausal period smoothly and to benefit fully from the advantages hormone replacement therapy offers in terms of treatment of short-term symptoms and long-term prevention by gradually replacing the waning estrogens.     

Non-contraceptive health benefits of intrauterine hormonal systems

Non-contraceptive health benefits are now recognized as an important aspect of the overall impact of all hormonal contraceptives. The levonorgestrel-releasing intrauterine systems (LNG IUS) are particularly effective at producing a number of health benefits for women using the LNG IUS as a contraceptive (reduced menstrual bleeding; reduced dysmenorrhea and the potential for prevention of a number of gynecological conditions in the longer term, such as iron-deficiency anemia, endometrial hyperplasia, uterine fibroids, acute episodes of pelvic inflammatory disease, endometriosis and perhaps others). The LNG IUS also has the potential to specifically treat a range of pre-existing gynecological conditions such as heavy menstrual bleeding due to a wide range of underlying causes, endometrial hyperplasia, uterine fibroids, adenomyosis, and endometriosis.These health benefits should be recognized as a key component in the decision-making process for individual women in choosing a specific type of hormonal or other contraceptive. Investment in research into the very substantial health benefits of hormonal contraceptives, such as the LNG IUS, has generally been ignored in comparison with the massive investment into understanding the often subtle or rare complications of hormonal contraceptive use. Both are important, but there is a real need to define more accurately those women who will benefit most from these health benefits.     

Assessment of menstrual blood loss in Belgian users of the frameless copper-releasing IUD with copper surface area of 200 mm2 and users of a copper-levonorgestrel-releasing intrauterine system

OBJECTIVE: This study was conducted to evaluate the effect of a miniaturized frameless copper IUD (GyneFix 200 small) and a copper-levonorgestrel (GynePlant) intrauterine system (IUS) on the amount of menstrual blood loss (MBL). METHODS: In 60 Belgian women using GyneFix 200 and 21 using GynePlant, MBL was assessed with the visual assessment technique. RESULTS: MBL scores in GyneFix 200 users did not change from baseline during the mean observation period of 31 months. In GynePlant users, mean MBL scores decreased by at least 50% in all but one user. CONCLUSION: The impact of copper IUDs on MBL can be minimized by reducing the surface area of the foreign body. Reduction of MBL, without causing amenorrhea, can be obtained by adding levonorgestrel.     

Subject and clinician experience with the levonorgestrel-releasing intrauterine system

BACKGROUND: Because use of intrauterine contraception is now expanding, this article reports early US clinical experience with the levonorgestrel-releasing intrauterine system (LNG IUS) and assesses subjects' and clinicians' judgment of the adequacy of product information and the overall level of product satisfaction in order to provide insight to new providers of the LNG IUS. STUDY DESIGN: Multicenter, open-label, uncontrolled, Phase IIIb study. Investigators had no prior experience with the LNG IUS. Subjects and investigators completed surveys and questionnaires at 3, 6 and 12 months. RESULTS: A total of 509 women, aged 18 to 45 years, were enrolled in this study between July 2000 and June 2002, and 506 (99.4%) received a LNG IUS after the first (488/506, 95.9%) or second (18/20, 90%) insertion attempt. Insertion was rated as "easy" by 91.8% of investigators. Continuation rate at 12 months was 79%. Primary reasons for premature discontinuation were expulsion (4.5%) and menstrual cycle problems (3.8%). Most subjects (84.5%) indicated a high level of satisfaction with the LNG IUS. CONCLUSION: Over 95% of women had successful insertions of the LNG IUS at first attempt, and less than 1% were unsuccessful after two attempts. Both clinicians and subjects were highly satisfied with product information and their experience with the LNG IUS. One-year continuation rates were comparable to those of other reversible methods.     

Menstrual blood loss in women using the frameless FibroPlant LNG-IUS

Background

This study was conducted to report on a menstrual blood loss (MBL) study and iron stores in women with and without heavy menstrual bleeding using the frameless FibroPlant^® levonorgestrel-releasing intrauterine system (LNG-IUS) for contraception.

Study design

An open, prospective, noncomparative MBL study, using FibroPlant^® releasing 14 mcg of LNG/day for contraception. MBL was assessed by the quantitative alkaline hematin (QAH) technique.

Results

The MBL study was conducted in 40 heavy and normally menstruating Brazilian women seeking contraception. MBL was reduced from a mean baseline menstrual volume of 29.7 mL to a mean volume of 1.5 mL after 24 months, while ferritin values increased from a mean value of 31.1 ng/mL (at baseline) to a mean level of 72.5 ng/mL (after 24 months of use). Differences were highly significant (p<.0005). There were no significant differences between those who had normal menstrual bleeding and the heavy bleeders. The heavy bleeders had comparable MBL to the normal bleeders 3 months after insertion, and by 24 months post-insertion, their ferritin levels were comparable to those of the normal bleeders. Amenorrhea occurred in 80% of women out of 40 after 24 months of use. No pregnancies were recorded.

Conclusion

The LNG-IUS is effective in reducing MBL in normally menstruating women as well as in women with heavy menstrual bleeding. The authors agree with the recommendations by the UK National Institute for Clinical Effectiveness and the new Finnish guidelines for heavy menstrual bleeding that the LNG-IUS should be positioned as first-line treatment prior to endometrial ablation or hysterectomy.     

月经卡评分估计子宫出血的有效性及其在临床研究中的应用

目的:评价月经卡评分用于估计子宫出血的有效性,并将之应用于评价妥塞敏预防育龄妇女放置IUD后子宫异常出血的疗效。方法:采用双盲的临床试验方法,将研究对象随机分配到妥塞敏全剂量组、半剂量组和安慰剂组,放置统一的IUD,记录月经卡评分,同时用碱性正铁血红蛋白法测定经血量。结果:月经卡评分与碱性正铁血红蛋白法测定结果存在高度相关性(r=0.612,P<0.001);ROC曲线下面积为0.775,以138分作为确定月经过多的合适界值,此时的灵敏度为77.3%,特异度为76.2%。评价妥塞敏预防放置IUD后子宫异常出血效果时,两法结果类似。结论:月经卡评分可有效估计子宫出血量,判断月经过多。     

Abnormal bleeding patterns associated with menorrhagia in women in the community and in women presenting to primary care

BACKGROUND: There is an assumption that in women with menorrhagia 'excessive menstrual loss in regular cycles is the most common clinical presentation' yet epidemiological studies show irregular cycles and bleeding are common. OBJECTIVES: To test the hypothesis that, in women who present to primary care with menorrhagia, excessive menstrual loss in regular cycles is the most common clinical presentation, and to determine the frequency with which symptoms known to be associated with gynaecological malignancy occur. METHODS: A postal survey of all women aged 18-54 years was used to identify symptoms of vaginal bleeding in an urban general practice with 10 000 registered patients. Follow-up surveys were carried out at 6 and 12 months. Consultation data from general practice held records were gathered from baseline to 18 months. Women who consulted with increased vaginal bleeding during the 18-month study period were separately analysed according to their self-reported symptoms in the questionnaire completed in the 6 months prior to the consultation. RESULTS: At baseline, of the 736 women in the community identified with menorrhagia, 46% had at least one symptom of irregular vaginal bleeding. In the subgroup of 138 women with menorrhagia who consulted primary care with increased vaginal bleeding, the proportion with at least one symptom of irregular vaginal bleeding was 73%. CONCLUSION: In women with heavy menstrual bleeding, excessive menstrual loss in regular cycles is not the most common clinical presentation in primary care. Guidelines on menorrhagia should acknowledge the variety of symptoms that women with heavy menstrual bleeding present to primary care.     

Clinical performance of a levonorgestrel-releasing intrauterine system and oral contraceptives in young nulliparous women: a comparative study

This 1-year randomized study was carried out at family-planning clinics of two university hospitals to compare the safety and acceptability of a levonorgestrel-releasing intrauterine system (LNG IUS) and oral contraceptives (OCs) in young nulliparous women. The study population consisted of 200 women aged 18-25 years seeking contraception. Ninety-four women entered the LNG IUS group and 99 entered the OC group. Continuation rates, reasons leading to discontinuation, adverse events, menstrual questionnaires, subjective well-being and sexual behavior were evaluated. Nineteen women (20%) in the LNG IUS group discontinued the study during the 1-year observation period, and 27 discontinued (27%) in the OC group. The most common reason (31%) for discontinuation in the IUS group was pain. In the OC group, hormonal side effects were the predominant medical reason for study termination. The safety and acceptability of the LNG IUS for contraception was observed to be as good as with OCs, with a high continuation rate.     

Amenorrhea rates and predictors during 1 year of levonorgestrel 52 mg intrauterine system use

Objective

The objective was to evaluate amenorrhea patterns and predictors of amenorrhea during the first year after levonorgestrel 52 mg intrauterine system (IUS) placement.

Bleeding and spotting with the levonorgestrel 13.5 mg intrauterine system: the impact of insertion timing

ObjectiveTo assess the impact of early versus late menstrual cycle insertion on bleeding/spotting in the 90 days following levonorgestrel (LNG) 13.5 mg intrauterine system (IUS) insertion.Study designIn this observational study, participants received a LNG 13.5 mg IUS and provided 90 days of bleeding/spotting data by answering the following daily text: “Have you had no flow (0), spotting (1), or bleeding (2) today?” We dichotomized insertion timing as early (days 1–7 from last menstrual period) and late (remainder of menstrual cycle) and compared bleeding/spotting between the two groups in the 90- and 30-day reference periods. We used multivariate regression methods to study associations between cycle day at insertion, parity, historical bleeding, recent hormonal contraceptive use and bleeding/spotting.ResultsIn the 90-day dichotomous analysis (n=125), we found no differences in the number of days of bleeding/spotting, bleeding or spotting between the early and late insertion groups. In the 30-day dichotomous analysis (n=131), early insertion was associated with fewer days of bleeding than late insertion (5±3 vs. 7±4 days, p<.01). Recent hormonal contraceptive users experienced fewer days of bleeding than new users (5±4 vs. 7±3 days, p<.01). In the 90- and 30-day regression models, earlier insertion was associated with fewer days of bleeding (p=.02, p=.02). Recent contraceptive use was associated with fewer days of bleeding/spotting (90-day, p=.03) and fewer days of bleeding (30-day, p<.01). Nulliparity was associated with spotting (30-day, p=.04).ConclusionsEarly cycle insertion does not impact 90-day bleeding/spotting. Early cycle insertion and recent hormonal contraceptive use decrease 30-day bleeding.ImplicationsThe LNG 13.5 mg IUS may be inserted throughout the menstrual cycle with small differences in bleeding patterns in the 30 but not the 90 days following insertion. Shared decision making should determine timing of insertion.     

Prospective, open-label, noncomparative study to assess cycle control, safety and acceptability of a new oral contraceptive containing gestodene 60 microg and ethinylestradiol 15 microg (Minesse)

OBJECTIVE: A prospective, open-label, noncomparative, multicenter study was carried out in 163 women aged 18-39 (mean 25+/-5 years), who used an ultra-low-dose oral contraceptive pill (OCP) containing gestodene (GTD) 60 mug/ethinylestradiol (EE) 15 mug for 6 months. The objective of the study was to evaluate the acceptability, safety, bleeding patterns and premenstrual symptomatology in these women. METHODS: Patients used the OCP from Days 1-24, followed by a 4-day pill-free interval from Days 25-28 of the menstrual cycle. Physical and gynecological examinations were carried out at baseline and after 3 and 6 months, at which time blood pressure, weight, hemoglobin, hematocrit, SGOT, SGPT and urinalysis were also assessed. The Moos Menstrual Distress Questionnaire (MDQ) was completed on three consecutive days (Days 25-27 of the cycle) at baseline and at the end of the third and sixth cycles. Patients kept a menstrual diary throughout the study. RESULTS: A total of 146 women completed the study. Ten women discontinued because of adverse events and one undesired pregnancy occurred during treatment. No adverse metabolic effects were observed. The adverse event most frequently reported was breakthrough bleeding, which diminished, however, as the time of OC use increased. Cycle length and duration of bleeding decreased significantly with OC use (p<.01 and p<.05, respectively, after 6 months). Intensity of menstrual bleeding tended to decrease with OC use, but this difference was not statistically significant. Systolic and diastolic blood pressure were significantly lower after 6 months of OC use compared to baseline (p<.02). No alterations were recorded in body weight or laboratory evaluations. Statistically significant changes were found both in the total MDQ score and in several of the factors evaluated, and patients showed a statistically significant improvement in well-being with respect to premenstrual complaints and symptoms. CONCLUSION: This OC regimen is safe, well-accepted and well-tolerated, affects menstrual patterns beneficially by reducing both the intensity and duration of bleeding, provides good cycle control and improves premenstrual symptomatology.     

Safety of levonorgestrel 52 mg intrauterine system compared to copper intrauterine device: a population-based cohort study

ObjectiveTo compare the risk of all-cause death, hospitalizations (any cause), ectopic pregnancy, pelvic inflammatory disease or infection, uterine perforation, device removal, neuro-psychiatric drugs initiation, or new psychiatric visit(s) between levonorgestrel (LNG) 52 mg intrauterine system (IUS) and copper intrauterine device (IUD) users in France.Study designWe identified a historical cohort of women aged 20–55 years with a first dispensing of either LNG 52 mg IUS or copper-IUD between January 1, 2010, and December 31, 2014, in the French National Claims database, SNDS. We used propensity score matching to balance the two groups on baseline sociodemographic and clinical characteristics to minimize confounding. We estimated Cox proportional hazards models to compare health outcomes between LNG 52 mg IUS and copper-IUDs users.ResultsWe matched 9318 LNG 52 mg IUS users (mean age 36.2±6.8 years) to 10,185 copper-IUD users (mean age 35.4±7.1 years). After matching and age-adjustment, LNG 52 mg IUS users had a slightly higher risk of anxiolytic drugs initiation (HR 1.08, 95%CI 1.01–1.15) and device removal (HR 1.05, 95%CI 1.01–1.10) compared to copper-IUD users, with no differences for other studied outcomes.ConclusionFrench IUS users report slightly more anxiolytic treatment initiation and IUD removal compared to copper-IUD users. These results are consistent with a potential pharmacovigilance signal of anxiety-related disorders in LNG 52 mg IUS users.Implications statementIn French LNG 52 mg IUS users, there was slightly more anxiolytic treatment initiation and IUD removal compared to copper-IUD users. No risk difference was found for all-cause death, hospitalizations, ectopic pregnancy, pelvic disorders, and uterine perforation. We cannot exclude that the associations are related to differences in characteristics of women who chose each type of type of IUD.     

左炔诺孕酮宫内缓释系统预防子宫内膜息肉复发的应用

目的:应用左炔诺孕酮宫内缓释系统(LNG-IUS,商品名曼月乐)与孕三烯酮预防功能性子宫内膜息肉,比较这两种治疗的优劣以及对妊娠结局的影响。方法:将60例有生育要求且合并功能性子宫内膜息肉患者按放置曼月乐或孕三烯酮药物治疗分曼月乐组和对照组。两组患者于宫腔镜下电切除术(HPE)后3~5d开始治疗方案,曼月乐组放置LNG-IUS;对照组患者口服孕三烯酮2.5mg∕次,2次∕周。连续治疗3个月。结果:3个月后曼月乐组子宫内膜息肉复发率为0%(0/30),对照组为13.3%(4/30);1年后复发率曼月乐组为3.3%(1/30),对照组为33.3%(10/30);2年复发率曼月乐组为10.0%(3/30),对照组为53.3%(16/30),曼月乐组与对照组比较差异均有统计学意义(P0.05)。结论:曼月乐IUS预防功能性子宫内膜息肉复发的效果优于孕三烯酮,值得临床应用。     

Clinical performance of the levonorgestrel intra-uterine system in routine use by the UK Family Planning and Reproductive Health Research Network: 12-month report

Doctors working in general practice and at family planning clinics throughout the UK who collaborate in the UK Family Planning and Reproductive Health Research Network were responsible for the fitting of 692 Levonorgestrel Intra-uterine Systems (LNG IUS). This study was undertaken to determine the performance of the LNG IUS in British women in routine clinical use. The 12 months cumulative life-table event rates were: pregnancy 0.6, expulsion 4.5. The continuation rate was 70.6. Removals were also required for side effects, which may be due to absorbed levonorgestrel, the removal rate being 7.4. Positive effects include effective contraception and considerably reduced quantity of bleeding for most participants. A need was identified to counsel women about the early bleeding problems, including the possibility of oligomenorrhoea or amenorrhoea. This is considered to be very important as it will help women to persevere so that they can enjoy the longer-term benefits.     

Menstrual blood loss in healthy Chinese women

Intrauterine contraceptive devices (IUDs) are commonly used in China, but uterine bleeding is the main problem. So far, the menstrual blood loss (MBL) is based on subjective judgments by the patients, and objective quantitative data of MBL is lacking. It is necessary to determine the baseline MBL of healthy Chinese women.MBL was determined in 131 healthy women for one period, the range was 7.5–176.5 ml; the mean value was 56.3±2.8 (S.E.) ml; the median was 50.8 ml; and the central percentile limits of 80% and 90% were 20.7–95.0 ml and 13.9–120.8 ml, respectively. The amount of MBL in 92.4% of tested subjects was within 100 ml; the 95th percentile was 120.8 ml. Hematological studies were made in 25 subjects. There was a tendency for the blood iron to decrease with increasing MBL and when the MBL reached 80–100 ml, the hemoglobin and hematocrit began to decline. When MBL increased to 100–120 ml, hemoglobin and hematocrit were reduced to the lower limit of normal value.Further investigation should be made to determine if 100 ml can be used as the upper limit of normal for Chinese women.     

The effect of a levonorgestrel-releasing intrauterine device in the treatment of myoma-related menorrhagia

In this open observational study we evaluated the effectiveness of a levonorgestrel-releasing intrauterine device (LNG-IUD) in the treatment of myoma-related menorrhagia. Nineteen patients with recurrent menorrhagia lasting more than 3 months and with fibromyomatosus uterus were treated for 12 months with a LNG-IUD releasing 20 micro g/day of levonorgestrel. Menstrual blood loss, measured objectively by the pictorial blood loss assessment chart score (PBAC), level of serum hemoglobin and pattern of uterine bleeding were recorded at 3, 6, 9 and 12-month follow-up visits. Median monthly PBAC score during the two menstrual cycles before treatment was 310. After LNG-IUD, the PBAC score gradually decreased from a median value of 186 at 3 months to a median value of 155, 108 and 96 at 6, 9 and 12 months of treatment, respectively. Despite the statistically significant reduction of PBAC score, persistent menorrhagia, defined as a monthly PBAC score of 100 or higher, was observed at 12 months in 14 patients, whereas only one woman was amenorrheic and 4 were hypomenorrheic. In conclusion our study demonstrates the clinical reduced effectiveness of LNG-IUD in the treatment of myoma-related menorrhagia.     

Uterine perforation in women using a levonorgestrel-releasing intrauterine system

OBJECTIVE: To determine an estimated incidence of uterine perforations related to the insertion of a levonorgestrel-releasing intrauterine system (LNG IUS) and to identify possible risk factors. DESIGN: Retrospective, case report study. SETTING: Hospitals in Limburg, the Netherlands. METHODS: Gynecologists in hospitals in Limburg were asked about uterine perforations related to the insertion of a LNG IUS between 1999 and 2002. The charts of the reported perforations were studied. Data on the patient, doctor, insertion, diagnosis and removal were collected for every reported uterine perforation. RESULTS: In Limburg, the estimated incidence of uterine perforations related to the insertion of a LNG IUS is 2.6 per 1000 insertions. Insertion in lactating women, even beyond 6 weeks after delivery, was shown to be an important risk factor. CONCLUSIONS: Complete registration of complications provides a greater insight into the actual incidence of LNG IUS-related uterine perforations and their possible consequences. This may eventually lead to a decrease in complications.