Evidence map›Paper›PMID 29409834›Full record

Trial reportContraception2018

Continuous dosing of a novel contraceptive vaginal ring releasing Nestorone® and estradiol: pharmacokinetics from a dose-finding study.

J T Jensen, A B Edelman, B A Chen, D F Archer, K T Barnhart, M A Thomas, A E Burke, C L Westhoff, L S Wan, R Sitruk-Ware and 3 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Contraception, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Trial
  2. Article
  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

13 authors.

J T JensenDepartment of Obstetrics & Gynecology, Oregon Health & Science University, Portland, OR. Electronic address: jensenje@ohsu.edu.
A B EdelmanDepartment of Obstetrics & Gynecology, Oregon Health & Science University, Portland, OR.
B A ChenDepartment of Obstetrics, Gynecology & Reproductive Sciences, Magee-Womens Research Institute, University of Pittsburgh School of Medicine, Pittsburgh, PA.
D F ArcherDepartment of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, VA.
K T BarnhartPennsylvania Clinical Research Center, Department of Obstetrics & Gynecology, University of Pennsylvania School of Medicine, Philadelphia, PA.
M A ThomasReproductive Medicine Research, Department of Obstetrics & Gynecology, University of Cincinnati College of Medicine, Cincinnati, OH.
A E BurkeDepartment of Gynecology and Obstetrics, The Johns Hopkins University School of Medicine, Baltimore, MD.
C L WesthoffDepartment of Obstetrics & Gynecology, Columbia University College of Physicians and Surgeons, New York, NY.
L S WanDepartment of Obstetrics & Gynecology, New York University School of Medicine, New York, NY.
R Sitruk-WareCenter for Biomedical Research, Population Council, New York, NY.
N KumarCenter for Biomedical Research, Population Council, New York, NY.
B VarianoCenter for Biomedical Research, Population Council, New York, NY.
D L BlitheContraceptive Development Program, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.

Funding

Oregon Clinical and Translational Research Institute - The National COVID Cohort Collaborative (N3C)UL1TR002369 · NCATS · OREGON HEALTH & SCIENCE UNIVERSITY · PI Cynthia D Morris, Christopher G. Slatore · 2017 to 2026
$78.4M
Clinical and Translational Science AwardUL1TR000040 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2012 to 2015
$26.2M
Development of novel contraceptive methods for men and womenZIBHD008987 · NICHD · EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT · PI BLITHE, DIANA · 2019 to 2025
$7.2M
Inflammatory cytokine-mediated induction of HIV cardiomyopathyK01RR024120 · NCRR · HARVARD MEDICAL SCHOOL · PI YEARLEY, JENNIFER · 2007 to 2008
$246k
NCATS NIH HHS UL1 TR002369NCRR NIH HHS K01 RR024120NICHD NIH HHS HHSN275200403378INICHD NIH HHS HHSN275201100043UNICHD NIH HHS HHSN275201300002INICHD NIH HHS HHSN275201300004INICHD NIH HHS HHSN275201300010INICHD NIH HHS HHSN275201300019INICHD NIH HHS HHSN275201300020I
6 · The paper itself

Abstract

backgroundAs part of a program to develop a novel estradiol-releasing contraceptive vaginal ring (CVR), we evaluated the pharmacokinetic (PK) profile of CVRs releasing segesterone acetate (Nestorone® (NES)) combined with one of three different estradiol (E STUDY

designA prospective, double-blind, randomized, multi-centered study to evaluate a 90-day CVR releasing NES [200mcg/day] plus E

resultsThe main study enrolled 197 women; 22 participated in the PK substudy. Baseline characteristics between the main and PK participants were comparable, with an average BMI of 25.8 kg/m

conclusionPK parameters of NES were not affected when paired with different doses of E IMPLICATIONS: While these novel estradiol-releasing combination contraceptive vaginal rings provided sustained release of contraceptive levels of Nestorone over 90 days, the E

Indexed as

Contraceptive Devices, FemaleAdultContraceptionContraceptive Agents, FemaleDose-Response Relationship, DrugDouble-Blind MethodEstradiolFemaleHumansNorprogesteronesProspective StudiesUnited StatesYoung AdultContraceptive Agents, FemaleEstradiolNorprogesteronesST 1435Continuous cyclingContraceptionContraceptive vaginal ringEstradiolNestoronePharmacokinetics

Identifiers

PMID29409834
PMCPMC5948142

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.