Evidence map›Paper›PMID 31138184›Full record

Trial reportBMC women's health2019

Norethindrone is superior to combined oral contraceptive pills in short-term delay of menses and onset of breakthrough bleeding: a randomized trial.

Joshua Dean, Katherine J Kramer, Fauzia Akbary, Shaunte Wade, Maik Hüttemann, Jay M Berman, Maurice-Andre Recanati

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC women's health, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03594604 (Norethindrone Versus Combined Oral Contraceptive Pills for the Delay of Menstruation), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.3field-weighted citation impact, top 19% 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.

NCT03594604 phase4completednot on this map

Norethindrone Versus Combined Oral Contraceptive Pills for the Delay of Menstruation

TypeinterventionalSponsorWayne State UniversityRan2007 to 2007Enrolled17ConditionsMenstrual Flow AlteredArmsNorethindrone, oral contraceptive pill
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 14 citations in OpenAlex.

  1. Review
  2. Article
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  4. Article
  5. 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

7 authors at 2 institutions in 1 country.

Joshua DeanSchool of Medicine, Wayne State University, Detroit, MI, 48201, USA.
Katherine J KramerDepartment of Obstetrics and Gynecology, St. Vincent's Catholic Medical Centers, New York, NY, 10011, USA.
Fauzia AkbaryWayne State University School of Medicine, Detroit, MI, 48201, USA.
Shaunte WadeSchool of Medicine, Wayne State University, Detroit, MI, 48201, USA.
Maik HüttemannCenter for Molecular Medicine and Genetics, Wayne State University School of Medicine, Detroit, MI, 48201, USA.
Jay M BermanDepartment of Obstetrics and Gynecology, Wayne State University, Detroit, MI, 48201, USA.
Maurice-Andre RecanatiNIH-Women's Reproductive Health Research (WRHR) Scholar, Department of Obstetrics and Gynecology, Wayne State University, Detroit, MI, 48201, USA. marecanati@gmail.com.ORCID 0000-0003-0974-3962
Wayne State University · USCatholic Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo determine whether oral norethindrone acetate is superior to combined oral contraceptives (OCP) in delaying menstruation and preventing breakthrough bleeding when started late in the cycle.

methodsThis article comprises of a case control study followed by a pilot randomized controlled study. In the first study, four women who presented late in their cycle and desired avoiding vaginal bleeding within 10 days before a wedding were started on norethindrone 5 mg three times daily and compared to age matched controls started on OCPs. Subsequently, a randomized controlled pilot study (n = 50) comparing OCPs to norethindrone for the retiming of menses was conducted. Percentage of women reporting spotting were compared with level of statistical significance set at p < 0.05.

resultsOf the norethindrone treated group, only 2 women (8%) reported spotting compared with 10 women (43%) in the control group (p < 0.01). Norethindrone recipients experienced significant weight gain, which resolved after cessation of therapy and had heavier withdrawal bleed (p < 0.04) when compared to controls. Patient satisfaction was significantly higher in the norethindrone group, with 80% willing to choose this method again. Time to conceive was significantly shorter in the norethindrone group (p < 0.03).

conclusionsNorethindrone, begun on or before cycle day 12, is superior for women who desire to avoid breakthrough bleeding and maintain fertility when compared to OCPs. It is an ideal approach in patients presenting late in their cycle and who desire delaying menses as well as in circumstances when even minute amounts of breakthrough bleeding cannot be tolerated.

trial registrationClinicaltrials.gov NCT03594604 , July 2018. Retrospectively registered.

Indexed as

AdultCase-Control StudiesContraceptives, Oral, CombinedContraceptives, Oral, SyntheticFemaleHumansMenstruationMenstruation DisturbancesNorethindronePilot ProjectsRetrospective StudiesUterine HemorrhageWeight GainContraceptives, Oral, CombinedContraceptives, Oral, SyntheticNorethindroneMenstruation delayNorethindroneRandomized controlled studyVaginal bleeding

Identifiers

PMID31138184
PMCPMC6537409
OpenAlexW2947173240

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.