Cited by 97Reproductive Health and ContraceptionInternational Human Rights and Reproductive LawReproductive System and Pregnancy

The DOI matches its Crossref record; 27 of the 27 references it cites were found in a registry or an index.

Use of the Etonogestrel Implant and Levonorgestrel Intrauterine Device Beyond the U.S. Food and Drug Administration–Approved Duration

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Abstract

OBJECTIVE: To evaluate the effectiveness of the contraceptive implant and the 52-mg hormonal intrauterine device (IUD) in women using the method beyond the current U.S. Food and Drug Administration (FDA)-approved duration of 3 and 5 years, respectively. METHODS: Women willing to continue using their implant or 52-mg levonorgestrel IUD beyond the FDA-approved duration were followed prospectively for contraceptive effectiveness. Unintended pregnancy rate per 100 women-years was calculated. Implant users are offered periodic venipuncture for analysis of serum etonogestrel levels. The Kruskal-Wallis test was used to compare the etonogestrel levels across body mass index (BMI) groups. RESULTS: Implant users (n=237) have contributed 229.4 women-years of follow-up, with 123 using the etonogestrel implant for 4 years and 34 using it for 5 years. Zero pregnancies have been documented, for a failure rate of 0 (one-sided 97.5% confidence interval [CI] 0-1.61) per 100 women-years. Among 263 levonorgestrel IUD users, 197.7 women-years of follow-up have been completed. One pregnancy was confirmed, for a failure rate of 0.51 (95% CI 0.01-2.82) per 100 women-years. Among implant users with serum etonogestrel results, the median and range of etonogestrel level at 3 years of use was 188.8 pg/mL (range 63.8-802.6 pg/mL) and 177.0 pg/mL (67.9-470.5 pg/mL) at 4 years of use. Etonogestrel levels did not differ by BMI at either time point (3 years: P=.79; 4 years: P=.47). CONCLUSION: Preliminary findings indicate the contraceptive implant and 52-mg hormonal IUD continue to be highly effective for an additional year beyond the FDA-approved 3 and 5 years. Serum etonogestrel levels indicate the implant contains adequate hormone for ovulation suppression at the end of both 3 and 4 years of use. LEVEL OF EVIDENCE: II.

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Metadata

Authors
McNicholas, C., Maddipati, R., Zhao, Q., Swor, E., & Peipert, J. F.
Affiliations
Washington University in St. Louis (US)
Venue
Obstetrics & Gynecology
Published
2015-03
Volume
125
Issue
3
Pages
599-604
ISSN
0029-7844 (ISSN-L)
OpenAlex
W2072207878
Cited by
97
References
27
Citations by year
2026: 6 · 2025: 8 · 2024: 6 · 2023: 8 · 2022: 7 · 2021: 6 · 2020: 9 · 2019: 8 · 2018: 8 · 2017: 12 · 2016: 8 · 2015: 11
FWCI
13.91
Type
journal article
Language
en
Open access
Locations
  • Obstetrics and Gynecology (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • National Institutes of Health (UL1TR000448)
  • National Center for Research Resources (UL1RR024992)
  • National Center for Advancing Translational Sciences
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (L50 HD081198, T32HD055172)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Reproductive Health and Contraception
  • Social Sciences › Political Science and International Relations › International Human Rights and Reproductive Law
  • Life Sciences › Immunology and Microbiology › Immunology › Reproductive System and Pregnancy
Keywords
etonogestrel implant, levonorgestrel intrauterine device, contraceptive effectiveness, body mass index, ovulation inhibition, hormonal contraception, contraceptive failure rate, long-acting reversible contraception
MeSH terms
Adolescent, Adult, Contraceptive Agents, Female, Female, Humans, Intrauterine Devices, Medicated, Prospective Studies, Time Factors, United States, United States Food and Drug Administration, Levonorgestrel, Desogestrel, Young Adult

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