Evidence map›Paper›PMID 25511238›Full record

ArticleAmerican journal of obstetrics and gynecology2015

Estimating systemic exposure to ethinyl estradiol from an oral contraceptive.

Carolyn L Westhoff, Malcolm C Pike, Rosalind Tang, Marianne N DiNapoli, Monica Sull, Serge Cremers

Open access · greenAbstract read
In one paragraph

Article in American journal of obstetrics and gynecology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 18% 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.

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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
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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

6 authors at 2 institutions in 1 country.

Carolyn L WesthoffDepartment of Obstetrics and Gynecology and Epidemiology, Columbia University Medical Center, New York, NY. Electronic address: clw3@columbia.edu.
Malcolm C PikeDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.
Rosalind TangDepartment of Obstetrics and Gynecology, Columbia University Medical Center, New York, NY.
Marianne N DiNapoliDepartment of Obstetrics and Gynecology, Columbia University Medical Center, New York, NY.
Monica SullDepartment of Obstetrics and Gynecology, Columbia University Medical Center, New York, NY.
Serge CremersPathology and Cell Biology, Columbia University Medical Center, New York, NY.
Columbia University Irving Medical Center · USMemorial Sloan Kettering Cancer Center · US

Funding

CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024156 · NCRR · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2006 to 2011
$53.0M
Clinical and Translational Science AwardUL1TR000040 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2012 to 2015
$26.2M
Institutional Career Development CoreKL2TR001874 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GENKINGER, JEANINE M., SHIMBO, DAICHI · 2016 to 2025
$13.6M
NCATS NIH HHS KL2 TR001874NCATS NIH HHS UL1 TR000040NCRR NIH HHS UL1 RR024156
6 · The paper itself

Abstract

objectiveThis study was conducted to compare single-dose pharmacokinetics of ethinyl estradiol in an oral contraceptive with steady-state values and to assess whether any simpler measures could provide an adequate proxy of the "gold standard" 24-hour steady-state area under the curve (AUC) value. Identification of a simple, less expensive measure of systemic ethinyl estradiol exposure would be useful for larger studies that are designed to assess the relationship between an individual's ethinyl estradiol exposure and side-effects. STUDY

designWe collected 13 samples over 24 hours for pharmacokinetic analysis on days 1 and 21 of the first cycle of a monophasic oral contraceptive that contained 30 μg ethinyl estradiol and 150 μg levonorgestrel in 17 nonobese healthy white women. We also conducted an abbreviated single-dose 9-sample pharmacokinetic analysis after a month washout. Ethinyl estradiol was measured by liquid chromatography-tandem mass spectrometry. We compared results of a full 13-sample steady-state pharmacokinetic analysis with results that had been calculated with the use of fewer samples (9 or 5) and after the single doses. We calculated Pearson correlation coefficients to evaluate the relationships between these estimates of systemic ethinyl estradiol exposure.

resultsThe AUC, maximum, and 24-hour values were similar after the 2 single oral contraceptive doses (AUC; r=0.92). The steady-state 13-sample 24-hour AUC value was correlated highly with the average 9-sample AUC value after the 2 single doses (r=0.81; P=.0002). This correlation remained the same if the number of single-dose samples was reduced to 4, taken at time 1, 2.5, 4, and 24 hours. The 24-hour value at steady-state was correlated highly with the 24-hour steady-state AUC value (r=0.92; P<.0001). The average of the 24-hour values after the 2 single doses was also correlated quite highly with the steady-state AUC value (r=0.72; P=.0026).

conclusionLimited blood sampling, including results from 2 single doses, gave highly correlated estimates of an oral contraceptive user's steady-state ethinyl estradiol exposure.

Indexed as

AdolescentAdultArea Under CurveContraceptives, Oral, CombinedDrug CombinationsEthinyl EstradiolFemaleHumansLevonorgestrelYoung AdultContraceptives, Oral, CombinedDrug CombinationsEthinyl Estradiolethinyl estradiol, levonorgestrel drug combinationLevonorgestrelethinyl estradioloral contraceptivepharmacokineticssingle-dosesteady-state

Identifiers

PMID25511238
PMCPMC4417052
OpenAlexW2012333288

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.