Extended use of levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg: A population pharmacokinetic approach to estimate in vivo levonorgestrel release rates and systemic exposure including comparison with two other LNG-IUSs.

Objective: To characterize performance of levonorgestrel-releasing intrauterine system (LNG-IUS) 52mg (Mirena) over 8 years of use and facilitate comparisons with LNG-IUS 19.5mg and LNG-IUS 13.5mg.

The effect of a combined indomethacin and levonorgestrel-releasing intrauterine system on short-term postplacement bleeding profile: a randomized proof-of-concept trial.

Background: Long-acting reversible contraceptives, including hormonal levonorgestrel-releasing intrauterine systems, are the most effective methods of reversible contraception. However, unfavorable bleeding, particularly during the first months of use, is one of the most important reasons for discontinuation or avoidance. Minimizing this as early as possible would be highly beneficial.

Contraceptive efficacy and safety of the 52-mg levonorgestrel intrauterine system for up to 8 years: findings from the Mirena Extension Trial.

Background: The 52-mg levonorgestrel-releasing intrauterine system is an established, long-acting contraceptive option with approved use for up to 7 years.

Objective: The Mirena Extension Trial evaluated the efficacy and safety of the 52-mg levonorgestrel-releasing intrauterine system during extended use beyond 5 and up to 8 years.

Study Design: This was a multicenter, single-arm study in the United States, enrolling existing users of the 52-mg levonorgestrel-releasing intrauterine system, aged 18 to 35 years, who have had the system for 4.

Thirty years of mirena: A story of innovation and change in women's healthcare.

Since its introduction in 1990, the levonorgestrel-releasing intrauterine system (LNG-IUS) has played a key role in shaping the healthcare landscape of women. Here we explore the development of the first LNG-IUS (Mirena®) and the early clinical trials that demonstrated its potential. We highlight the contraceptive and therapeutic benefits of Mirena®, and discuss how clinical practice has been changed since the introduction of LNG-IUS and other long-acting reversible contraceptive methods.

More than just contraception: the impact of the levonorgestrel-releasing intrauterine system on public health over 30 years.

Universal access to sexual and reproductive health services is essential to facilitate the empowerment of women and achievement of gender equality. Increasing access to modern methods of contraception can reduce the incidence of unplanned pregnancy and decrease maternal mortality. Long-acting reversible contraceptives (LARCs) offer high contraceptive efficacy as well as cost-efficacy, providing benefits for both women and healthcare systems.

Bleeding patterns with the 19.5 mg LNG-IUS, with special focus on the first year of use: implications for counselling.

The aim of the study was to provide an additional, detailed description of early bleeding patterns with the 19.5 mg levonorgestrel-releasing intrauterine system (LNG-IUS). We conducted a pooled analysis of the bleeding diaries of participants in a previously reported phase II randomised controlled study ( = 741) and a phase III study ( = 2904), with 2-year extension phase ( = 707), of the 19.

Overcoming barriers to levonorgestrel-releasing intrauterine system placement: an evaluation of placement of LNG-IUS 8 using the modified EvoInserter® in a majority nulliparous population.

Objectives: To report placement success rate, and ease and pain associated with placement, of the levonorgestrel-releasing intrauterine system (LNG-IUS) 8 using the modified EvoInserter® placement device.

Study Design: This was a pooled analysis using data from three previously reported Phase III studies in nulliparous (83.3%) or parous (16.

A single-arm phase III study exploring the efficacy and safety of LNG-IUS 8, a low-dose levonorgestrel intrauterine contraceptive system (total content 13.5 mg), in an Asia-Pacific population.

Objective: The objective was to evaluate the efficacy and safety of a low-dose levonorgestrel intrauterine system with total content 13.5 mg (average approximately 8 μg/24 h over the first year; LNG-IUS 8; Jaydess®) in an Asia-Pacific population.

Study Design: An open-label, single-arm phase III study conducted at 25 centers in China, Australia and Korea assessed LNG-IUS 8 use over 3 years in nulliparous and parous women (N=1114) aged 18-40 years with regular menstrual cycles (21-35 days).

A 12-month multicenter, randomized study comparing the levonorgestrel intrauterine system with the etonogestrel subdermal implant.

Objective: To compare the levonorgestrel intrauterine system (LNG-IUS 8), which has an average levonorgestrel release rate of ∼8 μg/24 hours during the first year (total levonorgestrel content 13.5 mg; Jaydess/Skyla), with the etonogestrel (ENG) subdermal implant (total content, 68 mg) with regard to the 12-month discontinuation rate (primary outcome).

Design: Randomized, open-label, phase III study.

A Phase III, single-arm study of LNG-IUS 8, a low-dose levonorgestrel intrauterine contraceptive system (total content 13.5mg) in postmenarcheal adolescents.

Objective: To assess the safety profile of the low-dose levonorgestrel intrauterine system (LNG-IUS) total content 13.5mg (average approximate release rate 8μg/24h over the first year; LNG-IUS 8; Jaydess®) in adolescents.

Study Design: In a Phase III study in 36 European centers, 304 healthy nulliparous or parous postmenarcheal adolescents (12-17years) received LNG-IUS 8 for 12months.

Bleeding patterns with the levonorgestrel-releasing intrauterine system when used for heavy menstrual bleeding in women without structural pelvic pathology: a pooled analysis of randomized controlled studies.

Background: The study was conducted to characterize the changes in bleeding pattern over time in women receiving the levonorgestrel-releasing intrauterine system (LNG-IUS) for heavy menstrual bleeding (HMB). The reduction in menstrual blood loss volume has been well documented elsewhere.

Study Design: Post hoc pooled analysis of the impact of the LNG-IUS on bleeding patterns in four comparator studies of medical and surgical treatment options for HMB.

Levonorgestrel-releasing intrauterine system for heavy menstrual bleeding improves hemoglobin and ferritin levels.

Background: We compared the effects of the levonorgestrel-releasing intrauterine system (LNG-IUS) with cyclic oral medroxyprogesterone acetate (MPA) on hemoglobin and serum ferritin levels in women with heavy menstrual bleeding (HMB).

Study Design: This was a multicenter, randomized study assessing the efficacy of the LNG-IUS and oral MPA (10 mg/day for 10 days) in women with confirmed HMB over 6 cycles of treatment. We previously reported that treatment with the LNG-IUS resulted in greater menstrual blood loss reduction than MPA.

The levonorgestrel-releasing intrauterine system provides a reliable, long-term treatment option for women with idiopathic menorrhagia.

Objectives: Idiopathic menorrhagia (IM) is an important clinical challenge. The levonorgestrel-releasing intrauterine system (LNG IUS) provides an effective treatment option as shown by multiple small clinical studies. In this analysis of combined data, we describe the time course of relative change in menstrual blood loss (MBL) from baseline up to 5 years.

A 60-month non-comparative study on bleeding profiles with the levonorgestrel intrauterine system from the late transition period to estrogen supplemented menopause.

Objectives: The primary aim of this study was to assess the transition from using the levonorgestrel-releasing intrauterine system (LNG IUS, 20 μg LNG/24 h) for reproductive-age contraception to using it as menopausal-age endometrial protection during estrogen replacement therapy (ERT). The transfer process was evaluated by assessment of the vaginal bleeding pattern. Continuation rates were also recorded.

Levonorgestrel-releasing intrauterine system or medroxyprogesterone for heavy menstrual bleeding: a randomized controlled trial.

Objective: To compare the efficacy and safety of the levonorgestrel-releasing intrauterine system and oral medroxyprogesterone acetate in the treatment of idiopathic heavy menstrual bleeding.

Methods: In this multicenter, randomized, controlled study, women aged 18 years or older with heavy menstrual bleeding (menstrual blood loss 80 mL or more per cycle) were randomly assigned to six cycles of treatment with either levonorgestrel-releasing intrauterine system or oral medroxyprogesterone acetate (10 mg daily for 10 days beginning on day 16 of each cycle). The primary efficacy variables were the absolute change in menstrual blood loss from baseline to end of study and the proportion of women with successful treatment (defined as menstrual blood loss less than 80 mL and a 50% or greater reduction in menstrual blood loss from baseline).

A Canadian, multicentre study comparing the efficacy of a levonorgestrel-releasing intrauterine system to an oral contraceptive in women with idiopathic menorrhagia.

Objectives: To evaluate the efficacy of a levonorgestrel-releasing intrauterine system (LNG-IUS) compared with a combined oral contraceptive containing 1 mg norethindrone acetate and 20 mg ethinyl estradiol (OC1/20) in reducing menstrual blood loss (MBL) in women with idiopathic menorrhagia.

Methods: A prospective, randomized, open-label study was conducted in nine centres in Canada. Healthy women over 30 years of age suffering from idiopathic menorrhagia were treated either with LNG-IUS (n = 20) or with OC1/20 (n = 19) over 12 months.

Pharmacokinetics, efficacy, and safety of intravesical formulation of oxybutynin in patients with detrusor overactivity.

Objective: To determine the pharmacokinetics of oxybutynin and its main active metabolite, N-desethyloxybutynin, after multiple dosage (5 mg/30 ml three times daily) of intravesical oxybutynin formulation. Furthermore, to determine the efficacy and safety of intravesical oxybutynin in the symptomatic relief of urge incontinence or urgency in adult patients with detrusor hyperreflexia or instability.

Material And Methods: Nine patients were randomly allocated to treatment with a special bladder instillation formulation of oxybutynin or placebo for two 14-day treatment periods in a double-blind, cross-over manner.