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

Philip D. Darney, Gretchen S. Stuart, Michael A. Thomas, Carrie Cwiak, Andrea Olariu, Mitchell D Creinin

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
JournalContraception
DOIs
StateAccepted/In press - Jan 1 2017

Fingerprint

Levonorgestrel
Amenorrhea
Hemorrhage
Contraception
Metrorrhagia
Parity
Multicenter Studies
Counseling

Keywords

  • Amenorrhea
  • Contraception
  • Intrauterine device
  • Intrauterine system
  • Levonorgestrel
  • Liletta

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

Amenorrhea rates and predictors during 1 year of levonorgestrel 52 mg intrauterine system use. / Darney, Philip D.; Stuart, Gretchen S.; Thomas, Michael A.; Cwiak, Carrie; Olariu, Andrea; Creinin, Mitchell D.

In: Contraception, 01.01.2017.

Research output: Contribution to journalArticle

Darney, Philip D. ; Stuart, Gretchen S. ; Thomas, Michael A. ; Cwiak, Carrie ; Olariu, Andrea ; Creinin, Mitchell D. / Amenorrhea rates and predictors during 1 year of levonorgestrel 52 mg intrauterine system use. In: Contraception. 2017.
@article{3de4f459bc5243aba6d2d0c8a0b43d10,
title = "Amenorrhea rates and predictors during 1 year of levonorgestrel 52 mg intrauterine system use",
abstract = "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{\circledR} 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.",
keywords = "Amenorrhea, Contraception, Intrauterine device, Intrauterine system, Levonorgestrel, Liletta",
author = "Darney, {Philip D.} and Stuart, {Gretchen S.} and Thomas, {Michael A.} and Carrie Cwiak and Andrea Olariu and Creinin, {Mitchell D}",
year = "2017",
month = "1",
day = "1",
doi = "10.1016/j.contraception.2017.10.005",
language = "English (US)",
journal = "Contraception",
issn = "0010-7824",
publisher = "Elsevier USA",

}

TY - JOUR

T1 - Amenorrhea rates and predictors during 1 year of levonorgestrel 52 mg intrauterine system use

AU - Darney, Philip D.

AU - Stuart, Gretchen S.

AU - Thomas, Michael A.

AU - Cwiak, Carrie

AU - Olariu, Andrea

AU - Creinin, Mitchell D

PY - 2017/1/1

Y1 - 2017/1/1

N2 - 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.

AB - 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.

KW - Amenorrhea

KW - Contraception

KW - Intrauterine device

KW - Intrauterine system

KW - Levonorgestrel

KW - Liletta

UR - http://www.scopus.com/inward/record.url?scp=85033709639&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85033709639&partnerID=8YFLogxK

U2 - 10.1016/j.contraception.2017.10.005

DO - 10.1016/j.contraception.2017.10.005

M3 - Article

C2 - 29038072

AN - SCOPUS:85033709639

JO - Contraception

JF - Contraception

SN - 0010-7824

ER -