Evidence map›Paper›PMID 26916172›Full record

Trial reportContraception2016

Safety and efficacy in parous women of a 52-mg levonorgestrel-medicated intrauterine device: a 7-year randomized comparative study with the TCu380A.

Patrick Rowe, Tim Farley, Alexandre Peregoudov, Gilda Piaggio, Simone Boccard, Sihem Landoulsi, Olav Meirik, IUD Research Group of the UNDP/UNFPA/WHO/World Bank Special Programme of Research; Development and Research Training in Human Reproduction

Erratum issued Registry-linked trialOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Contraception, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03395756 (Investigation of the Potential for Intramuscular Depot Medroxyprogesterone Acetate as Emergency Contraception), which is not on this map. Cited by 34 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 4 pooled it
11.5field-weighted citation impact, top 1% of its field
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.

NCT03395756 early_phase1completednot on this mapstarted 2018, after this paper: background citation

Investigation of the Potential for Intramuscular Depot Medroxyprogesterone Acetate as Emergency Contraception

TypeinterventionalSponsorUniversity of Southern CaliforniaRan2018 to 2020Enrolled30ConditionsEmergency Contraception, ContraceptionArmsDepot-Medroxyprogestereone Acetate
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 4 syntheses or guidelines pooled it, 95 citations in OpenAlex.

  1. Extended duration of use of long-acting reversible contraceptives: Systematic review.Canadian family physician Medecin de famille canadien · 2025
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Progestogen-releasing intrauterine systems for heavy menstrual bleeding.The Cochrane database of systematic reviews · 2020
    Pooled it
  5. Trial
  6. Article
  7. Article
  8. Trends in Continuation of Long-Acting Reversible Contraception Among Adolescents Receiving Medicaid.The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 2024
    Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Prioritisation of outpatient appointments and elective surgery in gynaecology.Best practice & research. Clinical obstetrics & gynaecology · 2021
    Review
  18. Continuation Rates of the 52-mg Levonorgestrel-releasing Intrauterine System according to the Primary Reason for its Use.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2021
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 3 countries.

Patrick RoweUNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Geneva, Switzerland.
Tim FarleyUNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Geneva, Switzerland.
Alexandre PeregoudovUNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Geneva, Switzerland.
Gilda PiaggioMedical Statistics Department, London School of Hygiene and Tropical Medicine, London, UK.
Simone BoccardUNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, Geneva, Switzerland.
Sihem LandoulsiDepartment of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
Olav MeirikInstituto Chileno de Medicina Reproductiva (ICMER), Santiago, Chile. Electronic address: meiriko@icmer.org.
IUD Research Group of the UNDP/UNFPA/WHO/World Bank Special Programme of Research; Development and Research Training in Human Reproduction
World Health Organization · CHInstituto Chileno de Medicina Reproductiva · CLLondon School of Hygiene & Tropical Medicine · GB

Funding

World Health Organization 001
6 · The paper itself

Abstract

objectivesTo compare rates of unintended pregnancy, method continuation and reasons for removal among women using the 52-mg levonorgestrel (daily release 20 microg) intrauterine device (LNG-IUD) or the copper T 380 A IUD (TCu380A). STUDY

designThis was an open-label 7-year randomized controlled trial in 20 centres, 11 of which in China. Data on 1884 women with interval insertion of the LNG-IUD and 1871 of the TCu380A were analysed using life tables with 30-day intervals and Cox proportional hazards models.

resultsThe cumulative 7-year pregnancy rate of the LNG-IUD was 0.5 (standard error 0.2) per 100, significantly lower than 2.5 (0.4) per 100 of the TCu380A, cumulative method discontinuation rates at 7 years were 70.6 (1.2) and 40.8 (1.3) per 100, respectively. Dominant reasons for discontinuing the LNG-IUD were amenorrhea (26.1 [1.3] per 100) and reduced bleeding (12.5 [1.1] per 100), particularly in Chinese women and, for the TCu380A, increased bleeding (9.9 [0.9] per 100), especially among non-Chinese women. Removal rates for pain were similar for the two intrauterine devices (IUDs). Cumulative rates of removal for symptoms compatible with hormonal side effects were 5.7 (0.7) and 0.4 (0.2) per 100 for the LNG-IUD and TCu380A, respectively, and cumulative losses to follow-up at 7 years were 26.0 (1.4) and 36.9 (1.3) per 100, respectively.

conclusionThe LNG-IUD and the TCu380A have very high contraceptive efficacy, with the LNG-IUD significantly higher than the TCu380A. Overall rates of IUD removals were higher among LNG-IUD users than TCu380A users. Removals for amenorrhea appeared culturally associated. IMPLICATIONS: The 52-mg LNG-IUD and the TCu380A have very high contraceptive efficacy through 7 years. As an IUD, the unique side effects of the LNG-IUD are reduced bleeding, amenorrhea and symptoms compatible with hormonal contraceptives.

Indexed as

Intrauterine Devices, CopperPregnancy, UnplannedAdultAmenorrheaContraceptive Agents, FemaleDevice RemovalFemaleHemorrhageHumansLevonorgestrelPatient SafetyPregnancyProportional Hazards ModelsTime FactorsContraceptive Agents, FemaleLevonorgestrelLevonorgestrel IUDMirena®Paragard®Randomized trialSeven yearsTCu380A

Identifiers

PMID26916172
PMCPMC5357727
OpenAlexW2293102563

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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.