Evidence map›Paper›PMID 35594123›Full record

ArticleObstetrics and gynecology2022

Effect of Topiramate on Serum Etonogestrel Concentrations Among Contraceptive Implant Users.

Aaron Lazorwitz, Morgan Pena, Jeanelle Sheeder, Stephanie Teal

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IEquivalence Trial
In one paragraph

Article in Obstetrics and gynecology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03335163 (The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 6% 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.

NCT03335163 phase1completednot on this map

The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users

TypeinterventionalSponsorUniversity of Colorado, DenverRan2018 to 2021Enrolled48ConditionsMigraine, Migraine, Menstrual, ContraceptionArmsTopiramate
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
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

4 authors at 1 institution in 1 country.

Aaron LazorwitzDivision of Family Planning, Department of Obstetrics and Gynecology, University of Colorado Anschutz Medical Campus, Aurora, Colorado; and the Department of Obstetrics and Gynecology, University Hospitals Cleveland Medical Center and Case Western Reserve University, Cleveland, Ohio.
Morgan Pena
Jeanelle Sheeder
Stephanie Teal
University of Colorado Anschutz Medical Campus · US

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

objectiveTo evaluate topiramate and etonogestrel pharmacokinetic interactions in contraceptive implant users.

methodsWe conducted a prospective, noninferiority study with healthy women using etonogestrel implants continuously for 12-36 months. We measured baseline serum etonogestrel concentrations and then began a 6-week titrated topiramate regimen to standard migraine (100 mg/day) and epilepsy (400 mg/day) dosages. We repeated serum etonogestrel concentrations at 3 weeks (100 mg/day), 4 weeks (200 mg/day), and 6 weeks (400 mg/day) of topiramate therapy. We measured etonogestrel using a validated liquid chromatography-tandem, mass-spectrometry assay and tested for noninferiority (less than 30% decrease) in serum etonogestrel concentrations from baseline.

resultsWe enrolled 48 total participants; 32 completed 3 weeks, 31 completed 4 weeks, and 27 completed all follow-up visits. Participants' median age was 25.3 years (range 18.3-37.2), median body mass index (BMI) was 25.5 kg/m2 (range 18.7-42.2), and median duration of implant use was 24 months (range 12-36). Median etonogestrel concentrations were 142 pg/mL (range 76.2-771) at baseline, 126 pg/mL (range 72.4-585) at 3 weeks, 119 pg/mL (range 65.6-542) at 4 weeks, and 105 pg/mL (46.2-859) at 6 weeks. The 95% CIs for mean percent change in serum etonogestrel concentrations from baseline were [-37.3%+16.9%], [-45.4%+5.2%], and [-66.8%+24.8%] at 3 weeks, 4 weeks, and 6 weeks, respectively. Excluding one participant who had a serum etonogestrel concentration less than 90 pg/mL at baseline, 30.8% of participants (8/26, 95% CI 14.3-51.8%) had a serum etonogestrel concentration less than 90 pg/mL at 6 weeks.

conclusionThough only a mild enzyme-inducing antiepileptic drug, concomitant topiramate use led to inferior serum etonogestrel concentrations among implant users, with a significant proportion reaching etonogestrel concentrations below the threshold for ovulatory suppression when taking antiepileptic dosages of topiramate. FUNDING SOURCE: This study was primarily funded through an Investigator-Initiated Study grant from Merck Sharp & Dohme Corp [MISP#57073]. This work was also supported by NIH/NCATS CTSA Grant Number UL1 TR001082 and NICHD K12 Women's Reproductive Health Research Scholar Program (grant number 5K12HD001271-18). CLINICAL

trial registrationClinicalTrials.gov, NCT03335163.

Indexed as

Contraceptive Agents, FemaleAdolescentAdultDesogestrelDrug ImplantsFemaleHumansProspective StudiesTopiramateYoung AdultContraceptive Agents, FemaleDesogestrelDrug ImplantsetonogestrelTopiramate

Identifiers

PMID35594123
PMCPMC9140306
OpenAlexW4220796676

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.