Improvement of laboratory markers of anaemia in the treatment of heavy menstrual bleeding with a 19.5-mg intrauterine device: a pilot study.

OBJECTIVES: To evaluate improvements in laboratory markers of anaemia (haemoglobin, haematocrit, serum iron, and ferritin) in women with subjective heavy menstrual bleeding (HMB) treated with the levonorgestrel 19.5-mg intrauterine device. MATERIALS AND METHODS: We conducted a pilot study at the Department of Obstetrics and Gynaecology, University of Campinas, Faculty of Medical Sciences, Campinas, SP, Brazil. We compared anaemia markers in 73 women aged 18-48 years suffering from HMB, one year after placement of the IUD. RESULTS: The mean age of participants was 30.0 years (range 24-38); more than half were white, and the mean body mass index (kg/m2) was 27.0. Twenty (27.4%) participants exited the study due to loss to follow-up (n = 12; 16.4%), expulsion (n = 7; 9.6%) and uterine perforation (n = 1; 1.4%). One-year post-IUD placement, amenorrhoea was reported by 10 (13.7%) women. According to intention-to-treat and per protocol analyses, the proportion of women with normal haemoglobin levels significantly improved (p = 0.014 in both analyses), as did haematocrit (p < 0.001 in both analyses) and serum iron (p = 0.003 in both analyses) compared to baseline evaluations. The proportion of women with normal ferritin levels also improved (p < 0.001) in both analyses using a cut-off of 15 ng/ml, though no significant difference was observed using a 30 ng/ml cut-off (p = 0.083 in both analyses). CONCLUSION: The levonorgestrel 19.5-mg IUD effectively improved laboratory markers of anaemia one year after placement in women with HMB.

Our results show that the levonorgestrel 19.5-mg IUD significantly improved anaemia markers in subjects with subjective HMB one year after insertion. The occurrence of expulsions emerged as a notable concern in this treatment group.

Ectopic Pregnancy Observed With Kyleena Intrauterine Device Use: A Case Report.

Kyleena (levonorgestrel 19.5 mg), a type of intrauterine device (IUD), has an efficacy rate of 99% in preventing pregnancy. Because the overall failure rate of IUDs is low, ectopic pregnancy (EP) with IUD use is uncommon. This case reports an EP observed in a female with the Kyleena IUD in place. She had no known risk factors for an EP, which makes this case noteworthy. Ultrasound and surgery confirmed a 4 cm EP in the ampulla of the left fallopian tube. Insufficient evidence exists to conclude whether the Kyleena IUD has a higher risk of EP compared to other hormonal IUDs. As the Kyleena IUD becomes a more popular option for women in search of an effective contraceptive, patients and clinicians should be aware of this potential risk. Our case emphasizes that continued research on the prevalence of EP with Kyleena use is necessary.

Pain and ease of insertion of three different intrauterine devices in Brazilian adolescents: A participant-blinded randomized trial.

OBJECTIVES: To compare pain and ease of insertion of the copper 380 mm2, levonorgestrel 52 mg, and levonorgestrel 19.5-mg intrauterine devices (IUDs) in Brazilian adolescents. STUDY DESIGN: We conducted a participant-blinded randomized trial at two clinics in Brazil. We enrolled 318 adolescents<19 years old in a 1:1:1 ratio from November 2021 to February 2022. We informed the adolescents about the IUD type inserted after they evaluated the pain associated with the IUD insertion using a Visual Analogue Scale and immediately after that the healthcare provider who placed the IUD evaluated the ease of the procedure. RESULTS: The VAS pain level was significantly higher after the levonorgestrel 52-mg IUD placement, median and [interquartile range, IQ] 8.0 [4.0] than the copper 380-mm2 IUD 7.0 [4.0], and the levonorgestrel 19.5-mg IUD 7.0 [6.0] (p = 0.001). The placement was easier after the copper 380-mm2 IUD (87/106, 82.1%) and the levonorgestrel 19.5-mg IUD (91/106, 85.8%) when compared with the levonorgestrel 52-mg IUD (75/105, 70.7%). After multiple logistic regression analyses, the higher VAS pain scores were associated with the levonorgestrel 52-mg IUD (OR = 2.90), low number of pregnancies (OR -0.48), and with a history of dysmenorrhea (OR = 2.67). CONCLUSIONS: The placement of the copper 380-mm2 IUD and the levonorgestrel 19.5-mg IUD was associated with lower pain according to the adolescent and was easier according to the provider when compared with the levonorgestrel 52-mg IUD. However, the small observed differences may not be clinically relevant. IMPLICATIONS: We found that the three types of IUDs were generally easy to place; however, mean pain scores were high during insertions. Our findings of high pain scores reinforce the need for interventions to reduce pain for adolescent IUD insertion.

Contemporary prescriptions pattern of different dose levonorgestrel-releasing intrauterine systems in an Italian service for family planning.

OBJECTIVE: Current research informations fail to adequately inform about when levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg is used instead of other lower dose LNG-IUSs (13.5 and 19.5 mg) and other long-acting reversible contraceptives (LARCs) in clinical practice. METHODS: A retrospective cohort study was performed in a third-level Service for Family Planning of Modena University hospital about all the first modern contraceptives prescriptions in the whole year 2019 performed by the same group of physicians. All women included underwent a detailed transvaginal ultrasound (TVUS) at prescription and a second evaluation within 3 months when they were still using the prescribed method. RESULTS: To 69/160 (43.1%) women a short-acting reversible contraceptive (SARC), while to 91/160 (56.9%) a LARC was prescribed. Women with a LARC prescription were older than them with a short-acting (SARC) (p < .0001). Women with LNG-IUS 52 mg prescription were significantly the oldest (42.9 ± 5.3), while those with intrauterine copper device and lower dose LNG-IUS were of similar age (36.5 ± 7.3 and 34.9 ± 2.3), significantly lower (p < .005). Women with implant prescription had the same age as SARC, being the youngest (30.7 ± 8.9 and 31.0 ± 9.5) (p < .0001). Women with LNG-IUS 52 mg prescription mg presented with bigger uterine volume (p = .001). In multivariate analyses, the LNG-IUS 52 mg prescription was significantly linked only to age (OR 1.24; 95% CI 1.11-1.37, p < .0001) and presence of adenomyosis (OR 4.56; 95% CI 1.45-14.33, p = .009). CONCLUSIONS: The use of LNG-IUS 52 mg instead of other LARCs is preferred for older women, with uteri of increased volume due to adenomyosis, suggesting a possible differential use of available LNG-IUSs in the contemporary clinical practice.

Levonorgestrel-releasing intra-uterine systems as female contraceptives.

INTRODUCTION: The availability and use of long-acting reversible contraceptives (LARCs), such as levonorgestrel intrauterine systems (LNG-IUSs), have increased in recent times. AREAS COVERED: The authors provide a narrative review of the LNG-IUSs currently available worldwide as female contraceptives (LNG-IUS 13.5, 19.5 and 52 mg). Specific features of the devices and their parameters of efficacy and tolerability were considered as outcomes. EXPERT OPINION: The one-handed 3.8-mm-diameter inserter of LNG-IUS 13.5 mg and 19.5 mg may be particularly suitable in nulliparous women. While LNG-IUSs 13.5, 19.5 mg and LNG 52 mg should be used by women simply looking for an effective contraceptive method for up to 3, 4 or 5 years, LNG-IUS 52 mg has also been approved for the treatment of heavy menstrual bleeding and endometrial protection during hormone replacement therapy. LNG-IUS 52 mg is ideal for women who are experiencing a certain hyperestrogenic hormonal environment, with heavy menstrual bleeding due to hormonal imbalances, adenomyosis or fibroids, in the case of symptomatic endometriosis or for endometrial protection during hormone estrogenic replacement therapy in non-hysterectomized women.

LNG-IUS 12: a 19.5 levonorgestrel-releasing intrauterine system for prevention of pregnancy for up to five years.

INTRODUCTION: Globally, intrauterine devices (IUDs) are the second most commonly used form of reversible contraception because of their high efficacy, safety, convenience and cost effectiveness. The levonorgestrel releasing intrauterine system with daily average release of 20 mcg (LNG-IUS 20) is the popular choice because of its favorable bleeding patterns and many noncontraceptive benefits. A three year (LNG-IUS 8) became available three years ago. More recently, the LNG-IUS 12 was added. This new IUD shares a smaller frame, narrow inserter and lower rate of amenorrhea with the LNG-IUS 8, but it offers the five years of contraceptive protection of the LNG-IUS 20. Areas covered: This article provides information on the contraceptive efficacy, safety and tolerability of this new IUS based on approximately 60,000 cycles of use. Where available, the impacts of subject age, parity and body mass index (BMI) on study outcomes are reported. Expert opinion: This new LNG-IUS 12 with mid-dose hormone levels, smaller frame and longer effective life fills a niche that may better meet the needs of women who might appreciate the narrow insertion tube and/or the lower rates of amenorrhea. Cost will ultimately help determine success.

Clarification of the role of the Jaydess(Skyla) LNG- IUS 13.5mg and Kyleena LNG-IUS 19.5mg as intrauterine contraceptive systems.

INTRODUCTION: Jaydess/Skyla and Kyleena are 'low dose' levonorgestrel releasing intrauterine systems(LNG-IUS). They differ from Mirena and other similar LNG-IUSs in terms of pharmacological properties and physical dimensions. There are currently no defined guidelines to decide when to use Jaydess or Kyleena or Mirena. Areas covered: MEDLINE, POPLINE, PubMed and clinicaltrials.gov were searched using the terms 'Jaydess', 'Skyla', LNG-IUS 13.5mg and 'Kyleena' LNG-IUS 19.5mg. Only clinical research articles as opposed to generalised reviews and opinion papers on the newer LNG-IUSs were considered for review. There were 10 clinical research articles and 11 clinical research abstracts relating to Jaydess/Skyla(LNG-IUS13.5mg) and Kyleena(LNG-IUS 19.5mg). All the studies were sponsored by the manufacturer. There were no independent clinical research studies. Expert commentary: The clinical research information from studies on Jaydess/Skyla and Kyleena does not adequately inform the clinician when and where these IUSs should be used in preference to other LNG-containing IUSs. The terminology used for describing the new low dose LNG-IUSs is inconsistent. The clinical differences between Jaydess, Kyleena and Mirena and the clinical differences in parity of subjects using Jaydess or Kyleena is used to generate an algorithm for helping clinicians choose between Mirena and Jaydess/Skyla or Kyleena.

Levonorgestrel-releasing intrauterine system (LNG-IUS 12) for prevention of pregnancy for up to five years.

INTRODUCTION: A new five-year low dose, smaller-framed, levonorgestrel-releasing intrauterine contraceptive system (LNG-IUS 12) has been introduced to complement the currently available systems. Areas Covered: This article will provide an overview of this new intrauterine system - its composition and its mechanisms of action as well as the results of the Phase II and III clinical trials of its efficacy, safety and tolerability. Expert Commentary: This new LNG-IUS 12 provides five-year contraceptive protection a pregnancy rate (less than 1%) in first year of use, which puts it into the top tier with the existing LNG-IUS 20 products; however, the LNG-IUS 12 does not have the high rates of amenorrhea often seen with the higher dose devices. On the other hand, this new IUD shares the smaller frame and narrower insertion tube with the lower dose LNG-IUS 8, but offers longer effective life.