Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system

Eisenberg, David L.; Schreiber, Courtney A.; Turok, David K.; Teal, Stephanie; Westhoff, Carolyn; Creinin, Mitchell D.

doi:10.1016/j.contraception.2015.04.006

Cited by 92 publications

(95 citation statements)

References 21 publications

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“…The methods of the primary study have been reported previously [9]. Briefly, investigators at 29 clinical sites in the United States enrolled healthy, nonpregnant, sexually active, nulliparous and parous women aged 16-45 years (inclusive) who desired a hormonal IUS for contraception from December 2009 to April 2013.…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2018

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Objective: The objective was to evaluate amenorrhea patterns and predictors of amenorrhea during the first year after levonorgestrel 52 mg intrauterine system (IUS) placement. Study design: This cohort analysis includes 1714 nulliparous and parous women who received a Liletta® levonorgestrel 52 mg IUS in a multicenter trial to evaluate efficacy and safety for up to 8 years. Participants maintained a daily diary with bleeding information. We assessed bleeding patterns in 90-day intervals; amenorrhea was defined as no bleeding or spotting in the preceding 90 days. We employed multivariable regression to identify predictors of amenorrhea at 12 months. The predictor analysis only included women not using a levonorgestrel IUS in the month prior to study enrollment. Results: In the month before enrollment, 148 and 1566 women, respectively, had used and not used a levonorgestrel IUS. Prior users averaged 50±19 months of use before IUS placement; 38.4% of these women reported amenorrhea at 12 months. Amenorrhea rates for non-prior-users at 3, 6, 9 and 12 months were 0.2%, 9.1%, 17.2% and 16.9%, respectively. During the first 12 months, 29 (1.7%) women discontinued for bleeding irregularities; no women discontinued for amenorrhea. The only significant predictor of amenorrhea at 12 months was self-reported baseline duration of menstrual flow of fewer than 7 days vs. 7 or more days (18.2% vs. 5.2%, adjusted odds ratio 3.70 [1.69, 8.07]). We found no relationships between 12-month amenorrhea rates and age, parity, race, body mass index, baseline flow intensity or hormonal contraception use immediately prior to IUS placement. Conclusions: Amenorrhea rates during the first year of levonorgestrel 52 mg IUS use are similar at 9 and 12 months. Amenorrhea at 12 months is most common among women with shorter baseline duration of menstrual flow. Implications statement: This information provides more data for clinicians when counseling women about amenorrhea expectations, especially since women seeking a levonorgestrel 52 mg IUS for contraception are different than women desiring treatment for heavy menstrual bleeding. Amenorrhea at 12 months is most common among women with shorter baseline duration of menstrual flow.

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Section: Methodsmentioning

confidence: 99%

“…This US study of women primarily using the LNG 52 mg IUS for contraception had significant proportions of obese and nulliparous women, which allowed for a broad, generalizable assessment of the characteristics of women who develop amenorrhea [9].…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2018

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“…The methods of this study have been reported previously [3]. A central or local Institutional Review Board for each center approved the study.…”

Section: Methodsmentioning

confidence: 99%

Bleeding patterns for the Liletta^® levonorgestrel 52 mg intrauterine system

Schreiber

Teal²,

Blumenthal

et al. 2018

The European Journal of Contraception & Reproductive Health

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Purpose: Evaluate bleeding patterns for the Liletta V R levonorgestrel 52 mg intrauterine system (IUS) using the World Health Organization Belsey definitions. Material and methods: This prospective multicenter trial evaluates the efficacy and safety of Liletta V R (Clinicaltrials.gov NCT00995150). We evaluated bleeding patterns for 1700 nulliparous and multiparous women using a daily diary completed by participants for the first 2 years and by questionnaire every 3 months thereafter. We assessed amenorrhea rates over 3 years and the proportion of subjects with infrequent, frequent, prolonged and irregular bleeding per 90-day reference period over 2 years for the entire study population as well as comparing nulliparous and parous women and obese and non-obese women. Results: Amenorrhea rates at 1 and 3 years in levonorgestrel 52 mg IUS users were 19 and 37%, respectively. The infrequent bleeding rate increased from 14% in the first 90 days to 30% at the end of Year 1, and was maintained at the same rate through Year 2. Frequent, prolonged and irregular bleeding declined to low levels by the end of the first year. Discontinuation for bleedingrelated complaints occurred in 35 (2.1%, 95% CI 1.3-2.7%) women during the first 36 months; only one subject discontinued for amenorrhea (in Year 2). Outcomes did not vary for nulliparous versus parous or obese versus non-obese women. Conclusions: Among Liletta users, amenorrhea and infrequent bleeding become more prevalent over time and amenorrhea rates continue to increase after the first year of use. Bleeding patterns do not differ significantly by parity or by obesity-status. Discontinuation for bleeding concerns is uncommon with this product. ARTICLE HISTORY

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“…A featured article in this print issue by David Eisenberg and colleagues [1] is the main report of the initial 3-year safety and efficacy results of the levonorgestrel intrauterine system, a new intrauterine system just approved by the U.S. Food and Drug Administration (FDA). This intrauterine system is deservedly much heralded in the U.S. where it will be available at a particularly low cost for public sector clinics (currently, 340B clinics), thus increasing access for many women.…”

Section: Introduction To Volume 92mentioning

confidence: 98%

Introduction to Volume 92

Westhoff¹

2015

Contraception

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Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system

Abstract: A new 52-mg levonorgestrel-releasing intrauterine system is effective and safe for nulliparous and parous women for at least 3 years.

Cited by 92 publications

References 21 publications

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

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

Bleeding patterns for the Liletta^® levonorgestrel 52 mg intrauterine system

Introduction to Volume 92

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Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system

Abstract: A new 52-mg levonorgestrel-releasing intrauterine system is effective and safe for nulliparous and parous women for at least 3 years.

Cited by 92 publications

References 21 publications

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

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

Bleeding patterns for the Liletta® levonorgestrel 52 mg intrauterine system

Introduction to Volume 92

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Product

Resources

About

Bleeding patterns for the Liletta^® levonorgestrel 52 mg intrauterine system