Evidence map›Paper›PMID 24813941›Full record

Trial reportContraception2014

Different Pearl Indices in studies of hormonal contraceptives in the United States: impact of study population.

Christoph Gerlinger, James Trussell, Uwe Mellinger, Martin Merz, Joachim Marr, Ralf Bannemerschult, Ilka Schellschmidt, Jan Endrikat

Abstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Contraception, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–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

8 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Male hormonal contraception: hope and promise.The lancet. Diabetes & endocrinology · 2017
    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

8 authors.

Christoph GerlingerBayer HealthCare Pharmaceuticals, 13353 Berlin, Germany; Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, 66421 Homburg/Saar, Germany. Electronic address: christoph.gerlinger@bayer.com.
James TrussellOffice of Population Research, Princeton University, Princeton, NJ 08544, USA; The Hull York Medical School, Hull HU6 7RX, UK.
Uwe MellingerBayer HealthCare Pharmaceuticals, 13353 Berlin, Germany.
Martin MerzBayer HealthCare Pharmaceuticals, 13353 Berlin, Germany.
Joachim MarrBayer HealthCare Pharmaceuticals, 13353 Berlin, Germany.
Ralf BannemerschultBayer HealthCare Pharmaceuticals, 13353 Berlin, Germany.
Ilka SchellschmidtBayer HealthCare Pharmaceuticals, 13353 Berlin, Germany.
Jan EndrikatBayer HealthCare Pharmaceuticals, 13353 Berlin, Germany; Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, 66421 Homburg/Saar, Germany.

Funding

Infrastructure for Population Research at PrincetonR24HD047879 · NICHD · PRINCETON UNIVERSITY · PI MASSEY, DOUGLAS S · 2004 to 2013
$7.3M
NICHD NIH HHS R24 HD047879NICHD NIH HHS R24HD047879
6 · The paper itself

Abstract

objectiveTo examine the impact of subject characteristics on efficacy as measured by the Pearl Index (PI) in clinical trials and to make study populations similar by matching.

methodsOur analysis used US data from four large Phase III studies. We compared results from one fertility control patch study with pooled data from three studies with virtually identical design on oral hormonal contraceptives. First, we identified three characteristics that had the most impact on the PI. Second, we used these three variables and matched subjects from the patch study with those from the oral contraceptive (OC) studies. Finally, we calculated the PIs for matched and unmatched subjects from both the patch study and the OC studies.

resultsA total of 3706 subjects were included in our analysis. The variables 'Hispanic ethnicity', 'previous pregnancy' and 'previous use of hormonal contraceptives' had the most impact on the PI. The PIs for the matched patch cohort and the matched OC cohort were 2.97 and 2.48, respectively. Those for the unmatched patch cohort and the unmatched OC cohort were 10.17 and 0.90, respectively.

conclusionSubject characteristics strongly influence the PI in clinical studies of hormonal contraceptives. In particular, Hispanic ethnicity, previous pregnancies and no previous use of hormonal contraceptives result in a higher PI. IMPLICATIONS: PIs from different clinical trials cannot be meaningfully compared unless subject characteristics that have most impact on the PI are similar or are made to be similar statistically as we did here by matching.

Indexed as

AdultAndrostenesCohort StudiesContraceptive Agents, FemaleContraceptives, Oral, HormonalEstradiolEthinyl EstradiolEuropeFemaleHumansIntention to Treat AnalysisMatched-Pair AnalysisNandroloneNorpregnenesPregnancyPregnancy, UnwantedAndrostenesContraceptive Agents, FemaleContraceptives, Oral, HormonaldienogestdrospirenoneEstradiolEthinyl EstradiolGestodeneNandroloneNorpregnenesProgestinsContraceptionContraceptive failurePearl IndexStudy populationSubject characteristics

Identifiers

PMID24813941
PMCPMC4096582

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.