Trial reportPloS one2015
The Effect of Age, Parity and Body Mass Index on the Efficacy, Safety, Placement and User Satisfaction Associated With Two Low-Dose Levonorgestrel Intrauterine Contraceptive Systems: Subgroup Analyses of Data From a Phase III Trial.
Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00528112 (Multi-Center, Open-Label, Randomized Study to Assess the Safety and Contraceptive Efficacy of Two Doses), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled 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.
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.
Multi-Center, Open-Label, Randomized Study to Assess the Safety and Contraceptive Efficacy of Two Doses ( in vitro12 µg/24h and 16 µg/24h) of the Ultra Low Dose Levonorgestrel Contraceptive Intrauterine Systems (LCS) for a Maximum of 3 Years in Women 18 to 35 Years of Age and an Extension Phase of the 16µg/24h Dose Group (LCS16 Arm) up to 5 Years
Who cites it
10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 63 citations in OpenAlex.
- Discontinuation rates of intrauterine contraception due to unfavourable bleeding: a systematic review.BMC women's health · 2022Pooled it
- Hormonal contraceptives for contraception in overweight or obese women.The Cochrane database of systematic reviews · 2016Pooled it
- One-year follow up of contraceptive use and pregnancy rates after early medical abortion: Secondary outcomes from a randomized controlled trial of immediate post-abortion placement of intrauterine devices.Acta obstetricia et gynecologica Scandinavica · 2023Trial
- The use of a menstrual cup as a risk factor for displacement of intrauterine devices: a case-control study.Contraception and reproductive medicine · 2025Article
- Satisfaction with the Levonorgestrel 19.5-mg Intrauterine Device Treatment for Heavy Menstrual Bleeding: A Pilot Study.Open access journal of contraception · 2025Article
- The use of LNG-IUS-19.5 mg in daily gynecological routine practice in Germany: data from the Kyleena™ Satisfaction Study (KYSS).Archives of gynecology and obstetrics · 2024Observational
- Digital Medical Device Companion (MyIUS) for New Users of Intrauterine Systems: App Development Study.JMIR medical informatics · 2021Article
- Levonorgestrel-Releasing Intrauterine System as a Contraceptive Method in Nulliparous Women: A Systematic Review.Journal of clinical medicine · 2020Review
- Do Adolescent Women's Contraceptive Preferences Predict Method Use and Satisfaction? A Survey of Northern California Family Planning Clients.The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 2019Article
- New developments in long-acting reversible contraception: the promise of intrauterine devices and implants to improve family planning services.Fertility and sterility · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTwo low-dose levonorgestrel intrauterine contraceptive systems (LNG-IUSs; total content 13.5 mg [average approx. 8 μg/24 hours over the first year; LNG-IUS 8] and total content 19.5 mg [average approx. 13 μg/24 hours over the first year; LNG-IUS 13]) have previously been shown to be highly effective (3-year Pearl Indices: 0.33 and 0.31, respectively), safe and well tolerated. The present subgroup analyses evaluated whether or not outcomes were affected by parity, age (18-25 vs 26-35 years), or body mass index (BMI, <30 vs ≥30 kg/m2).
methodsNulliparous and parous women aged 18‒35 years with regular menstrual cycles (21‒35 days) requesting contraception were randomized to 3 years of LNG-IUS 8 or LNG-IUS 13 use.
resultsIn the LNG-IUS 8 and LNG-IUS 13 groups, 1432 and 1452 women, respectively, had a placement attempted and were included in the full analysis set; 39.2%, 39.2% and 17.1% were 18-25 years old, nulliparous and had a BMI ≥30 kg/m2, respectively. Both systems were similarly effective regardless of age, parity or BMI; the subgroup Pearl Indices had widely overlapping 95% confidence intervals. Placement of LNG-IUS 8 and LNG-IUS 13 was easier (p < 0.0001) and less painful (p < 0.0001) in women who had delivered vaginally than in women who had not. The complete/partial expulsion rate was 2.2-4.2% across all age and parity subgroups and higher in parous than in nulliparous women (p = 0.004). The incidence of pelvic inflammatory disease was 0.1-0.6% across all age and parity subgroups: nulliparous and younger women were not at higher risk than parous and older women, respectively. The ectopic pregnancy rate was 0.3-0.4% across all age and parity subgroups. Across all age and parity subgroups, the 3-year completion rate was 50.9-61.3% for LNG-IUS 8 and 57.9-61.1% for LNG-IUS 13, and was higher (p = 0.0001) among older than younger women in the LNG-IUS 8 group only.
conclusionsLNG-IUS 8 and LNG-IUS 13 were highly effective, safe and well tolerated regardless of age or parity.
trial registrationClinical trials.gov NCT00528112.
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