Evidence map›Paper›PMID 25730221›Full record

Observational studyObstetrics and gynecology2015

Use of the etonogestrel implant and levonorgestrel intrauterine device beyond the U.S. Food and Drug Administration-approved duration.

Colleen McNicholas, Ragini Maddipati, Qiuhong Zhao, Erin Swor, Jeffrey F Peipert

Abstract readObservational Study
In one paragraph

Observational study in Obstetrics and gynecology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Extended duration of use of long-acting reversible contraceptives: Systematic review.Canadian family physician Medecin de famille canadien · 2025
    Pooled it
  3. Progestogen-releasing intrauterine systems for heavy menstrual bleeding.The Cochrane database of systematic reviews · 2020
    Pooled it
  4. Guideline
  5. Trial
  6. Trial
  7. Compounded hormonal pellets: a critical review of current evidence and risks.Revista da Associacao Medica Brasileira (1992) · 2025
    Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Review
  14. Prioritisation of outpatient appointments and elective surgery in gynaecology.Best practice & research. Clinical obstetrics & gynaecology · 2021
    Review
  15. Article
  16. Contraception for AdolescentsJournal of clinical research in pediatric endocrinology · 2020
    Article
  17. Article
  18. Article
  19. Article
  20. Postpartum intrauterine device placement: a patient-friendly option.Contraception and reproductive medicine · 2018
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Colleen McNicholasDivision of Clinical Research, Department of Obstetrics and Gynecology, Washington University in St. Louis School of Medicine, St. Louis, Missouri.
Ragini Maddipati
Qiuhong Zhao
Erin Swor
Jeffrey F Peipert

Funding

Washington University Institute of Clinical and Translational Sciences (UL1)UL1RR024992 · NCRR · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2007 to 2011
$45.4M
Washington University Institute of Clinical and Translational SciencesUL1TR000448 · NCATS · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2012 to 2016
$41.4M
Reproductive Epidemiology Training Program at Washington University in St. LouisT32HD055172 · NICHD · WASHINGTON UNIVERSITY · PI MADDEN, TESSA · 2009 to 2018
$2.5M
NCATS NIH HHS UL1 TR000448NCRR NIH HHS UL1 RR024992NICHD NIH HHS L50 HD081198NICHD NIH HHS T32 HD055172NICHD NIH HHS T32HD055172
6 · The paper itself

Abstract

objectiveTo 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.

methodsWomen 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.

resultsImplant 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).

conclusionPreliminary 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.

Indexed as

Intrauterine Devices, MedicatedAdolescentAdultContraceptive Agents, FemaleDesogestrelFemaleHumansLevonorgestrelProspective StudiesTime FactorsUnited StatesUnited States Food and Drug AdministrationYoung AdultContraceptive Agents, FemaleDesogestreletonogestrelLevonorgestrel

Identifiers

PMID25730221
PMCPMC4347947

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.