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A 12-month multicenter, randomized study comparing the levonorgestrel intrauterine system with the etonogestrel subdermal implant.
Fertil Steril 2016; 106(1):151-157.e5FS

Abstract

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.

SETTING

Thirty-eight centers in six European countries.

PATIENT(S)

Study population of 766 healthy nulliparous and parous women aged 18-35 years.

INTERVENTION(S)

The LNG-IUS 8 or the ENG implant.

MAIN OUTCOME MEASURE(S)

Discontinuation rate, by treatment group, at Month 12.

RESULT(S)

The 12-month discontinuation rates were 19.6% and 26.8% in the LNG-IUS 8 and ENG implant groups, respectively. The -7.2% difference was statistically significant (95% confidence interval -13.2%, -1.2%). Fewer women in the LNG-IUS 8 group than in the ENG implant group discontinued because of increased bleeding (3.2% vs. 11.3%) or adverse events (14.3% vs. 21.8%). At 12 months, more women in the LNG-IUS 8 group than in the ENG implant group were "very/somewhat satisfied" with their bleeding pattern (60.9% vs. 33.6%) and reported a preference to use their study treatment after study completion (70.1% vs. 58.5%).

CONCLUSION(S)

The LNG-IUS 8 was associated with a significantly lower 12-month discontinuation rate compared with the ENG implant; mainly because ENG implant users frequently discontinued due to increased bleeding. More LNG-IUS 8 users than ENG implant users reported being "very/somewhat satisfied" with their bleeding pattern, and reported a preference to continue using their study treatment after the study.

CLINICAL TRIAL REGISTRATION NUMBER

NCT01397097.

Authors+Show Affiliations

VL-Medi Clinical Research Center, Helsinki, Finland. Electronic address: dan.apter@vlmedi.fi.May Logan Centre, Bootle, United Kingdom.Lääkäriasema Cantti Oy, Kuopio, Finland.Bayer Pharma AG, Wuppertal, Germany.Bayer Oy, Espoo, Finland.Bayer HealthCare Pharmaceuticals, Whippany, New Jersey.Division of Obstetrics and Gynecology, Department of Women's and Children's Health, Karolinska Institutet/Karolinska University Hospital, Stockholm, Sweden.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27016644

Citation

Apter, Dan, et al. "A 12-month Multicenter, Randomized Study Comparing the Levonorgestrel Intrauterine System With the Etonogestrel Subdermal Implant." Fertility and Sterility, vol. 106, no. 1, 2016, pp. 151-157.e5.
Apter D, Briggs P, Tuppurainen M, et al. A 12-month multicenter, randomized study comparing the levonorgestrel intrauterine system with the etonogestrel subdermal implant. Fertil Steril. 2016;106(1):151-157.e5.
Apter, D., Briggs, P., Tuppurainen, M., Grunert, J., Lukkari-Lax, E., Rybowski, S., & Gemzell-Danielsson, K. (2016). A 12-month multicenter, randomized study comparing the levonorgestrel intrauterine system with the etonogestrel subdermal implant. Fertility and Sterility, 106(1), pp. 151-157.e5. doi:10.1016/j.fertnstert.2016.02.036.
Apter D, et al. A 12-month Multicenter, Randomized Study Comparing the Levonorgestrel Intrauterine System With the Etonogestrel Subdermal Implant. Fertil Steril. 2016;106(1):151-157.e5. PubMed PMID: 27016644.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A 12-month multicenter, randomized study comparing the levonorgestrel intrauterine system with the etonogestrel subdermal implant. AU - Apter,Dan, AU - Briggs,Paula, AU - Tuppurainen,Marjo, AU - Grunert,Julia, AU - Lukkari-Lax,Eeva, AU - Rybowski,Sarah, AU - Gemzell-Danielsson,Kristina, Y1 - 2016/03/24/ PY - 2016/01/05/received PY - 2016/02/23/revised PY - 2016/02/24/accepted PY - 2016/3/27/entrez PY - 2016/3/27/pubmed PY - 2017/7/14/medline KW - LARC KW - LNG-IUS KW - contraception KW - discontinuation KW - etonogestrel implant SP - 151 EP - 157.e5 JF - Fertility and sterility JO - Fertil. Steril. VL - 106 IS - 1 N2 - 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. SETTING: Thirty-eight centers in six European countries. PATIENT(S): Study population of 766 healthy nulliparous and parous women aged 18-35 years. INTERVENTION(S): The LNG-IUS 8 or the ENG implant. MAIN OUTCOME MEASURE(S): Discontinuation rate, by treatment group, at Month 12. RESULT(S): The 12-month discontinuation rates were 19.6% and 26.8% in the LNG-IUS 8 and ENG implant groups, respectively. The -7.2% difference was statistically significant (95% confidence interval -13.2%, -1.2%). Fewer women in the LNG-IUS 8 group than in the ENG implant group discontinued because of increased bleeding (3.2% vs. 11.3%) or adverse events (14.3% vs. 21.8%). At 12 months, more women in the LNG-IUS 8 group than in the ENG implant group were "very/somewhat satisfied" with their bleeding pattern (60.9% vs. 33.6%) and reported a preference to use their study treatment after study completion (70.1% vs. 58.5%). CONCLUSION(S): The LNG-IUS 8 was associated with a significantly lower 12-month discontinuation rate compared with the ENG implant; mainly because ENG implant users frequently discontinued due to increased bleeding. More LNG-IUS 8 users than ENG implant users reported being "very/somewhat satisfied" with their bleeding pattern, and reported a preference to continue using their study treatment after the study. CLINICAL TRIAL REGISTRATION NUMBER: NCT01397097. SN - 1556-5653 UR - https://www.unboundmedicine.com/medline/citation/27016644/A_12_month_multicenter_randomized_study_comparing_the_levonorgestrel_intrauterine_system_with_the_etonogestrel_subdermal_implant_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0015-0282(16)30009-7 DB - PRIME DP - Unbound Medicine ER -