Evidence map›Paper›PMID 37331464›Full record

Trial reportContraception2023

Validation of 24-hour trough concentration as a proxy for intensive pharmacokinetic measurements for a combined oral contraceptive pill containing desogestrel.

Aaron Lazorwitz, Jeanelle Sheeder

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in Contraception, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05002738 (Validation of 24-hour Trough Concentration as a Surrogate for Intensive Pharmacokinetic Measurements for a Combined Oral Contraceptive Pill Containing Desogestrel), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT05002738 phase4completednot on this map

Validation of 24-hour Trough Concentration as a Surrogate for Intensive Pharmacokinetic Measurements for a Combined Oral Contraceptive Pill Containing Desogestrel

TypeinterventionalSponsorUniversity of Colorado, DenverRan2021 to 2022Enrolled22ConditionsContraceptionArmsDesogestrel and Ethinyl Estradiol Tablets
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

2 authors.

Aaron LazorwitzDivision of Family Planning, Department of Obstetrics and Gynecology, University of Colorado Anschutz Medical Campus, Aurora, CO, United States. Electronic address: aaron.lazorwitz@cuanschutz.edu.
Jeanelle SheederDivision of Family Planning, Department of Obstetrics and Gynecology, University of Colorado Anschutz Medical Campus, Aurora, CO, United States. Electronic address: Jeanelle.sheeder@cuanschutz.edu.

Funding

NIH Prior Approval Process ProfessionalUL1TR002535 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2018 to 2022
$51.1M
Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
COLORADO WRHR CAREER DEVELOPMENT CENTERK12HD001271 · NICHD · UNIVERSITY OF COLORADO DENVER · PI Saketh R Guntupalli · 1999 to 2026
$8.9M
NCATS NIH HHS UL1 TR001082NCATS NIH HHS UL1 TR002535NICHD NIH HHS K12 HD001271
6 · The paper itself

Abstract

objectivesTo confirm that 24-hour steady-state trough measurements (C STUDY

designWe conducted a 12-sample, 24-hour pharmacokinetic study in healthy reproductive-age females taking a COCP containing 0.15-mg desogestrel (DSG) and 30-μg ethinyl estradiol (EE). As DSG is a pro-drug for etonogestrel (ENG), we calculated correlations between steady-state C

resultsAmong 19 participants at steady state, C

conclusionsSteady-state 24-hour trough concentrations are high-quality proxies for gold standard pharmacokinetics of a DSG-containing COCP. IMPLICATIONS: Use of single-time trough concentration measurements at steady state provides excellent surrogate results for gold standard AUC values for both DSG and EE among COCP users. These findings support that large studies exploring interindividual variability in COCP pharmacokinetics can avoid the time- and resource-intensive costs associated with measuring AUC. CLINICAL

trial registrationClinicaltrials.gov, NCT05002738.

Indexed as

Contraceptives, Oral, CombinedDesogestrelContraceptive DevicesEthinyl EstradiolFemaleHumansContraceptives, Oral, CombinedDesogestrelEthinyl EstradiolCombined oral contraceptive pillsDesogestrelEthinyl estradiolPharmacokineticsSteady state

Identifiers

PMID37331464
PMCPMC10528283

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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.