Evidence map›Paper›PMID 26212489›Full record

Trial reportThe European journal of contraception & reproductive health care : the official journal of the European Society of Contraception2015

Unique effects on hepatic function, lipid metabolism, bone and growth endocrine parameters of estetrol in combined oral contraceptives.

Marie Mawet, Catherine Maillard, Christine Klipping, Yvette Zimmerman, Jean-Michel Foidart, Herjan J T Coelingh Bennink

Abstract readClinical Trial, Phase IIControlled Clinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
5.0field-weighted citation impact, top 5% 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

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 94 citations in OpenAlex.

  1. Pooled it
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  7. Review
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  14. Article
  15. Estetrol: A New Choice for Contraception.Journal of clinical medicine · 2021
    Review
  16. Estetrol and Mammary Gland: Friends or Foes?Journal of mammary gland biology and neoplasia · 2021
    Review
  17. Review
  18. Article
  19. Article
  20. 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

6 authors at 3 institutions in 2 countries.

Marie Maweta * Estetra SPRL , Liège , Belgium.
Catherine Maillarda * Estetra SPRL , Liège , Belgium.
Christine Klippingb Dinox BV, Groningen , the Netherlands.
Yvette Zimmermanc Pantarhei Bioscience BV , Zeist , the Netherlands.
Jean-Michel Foidarta * Estetra SPRL , Liège , Belgium.
Herjan J T Coelingh Benninkc Pantarhei Bioscience BV , Zeist , the Netherlands.
University of Liège · BEPantarhei Bioscience (Netherlands) · NLBeatrix Kinderziekenhuis · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesEstetrol (E4) is a natural estrogen produced by the human fetal liver. In combination with drospirenone (DRSP) or levonorgestrel (LNG), E4 blocks ovulation and has less effect on haemostatic biomarkers in comparison with ethinylestradiol (EE) combined with DRSP. This study evaluates the impact of several doses of E4/DRSP and E4/LNG on safety parameters such as liver function, lipid metabolism, bone markers and growth endocrine parameters.

methodsThis was a dose-finding, single-centre, controlled study performed in healthy women aged 18 to 35 years with a documented pretreatment ovulatory cycle. Participants received 5 mg or 10 mg E4/3 mg DRSP; 5 mg, 10 mg or 20 mg E4/150 μg LNG; or 20 μg EE/3 mg DRSP as a comparator for three consecutive cycles in a 24/4-day regimen. Changes from baseline to end of treatment in liver parameters, lipid metabolism, bone markers and growth endocrinology were evaluated.

resultsA total of 109 women were included in the study. Carrier proteins were minimally affected in the E4/DRSP and E4/LNG groups, in comparison with the EE/DRSP group, where a significant increase in sex hormone-binding globulin was observed. Similarly, minor effects on lipoproteins were observed in the E4 groups, and the effects on triglycerides elicited by the E4 groups were significantly lower than those in the EE/DRSP group. No imbalances in bone markers were observed in any groups. No alterations in insulin-like growth factor were observed in the E4 groups.

conclusionsE4-containing combinations have a limited effect on liver function, lipid metabolism, and bone and growth endocrine parameters.

Indexed as

AdolescentAdultAlkaline PhosphataseAndrostenesAspartate AminotransferasesCholesterol, HDLCholesterol, LDLCollagen Type IContraceptives, Oral, CombinedContraceptives, Oral, SyntheticEstetrolEstrogensEthinyl EstradiolFemalegamma-GlutamyltransferaseGrowth HormoneAlkaline PhosphataseAndrostenesAspartate AminotransferasesCholesterol, HDLCholesterol, LDLCollagen Type Icollagen type I trimeric cross-linked peptideContraceptives, Oral, CombinedContraceptives, Oral, SyntheticdrospirenoneEstetrolEstrogensEthinyl Estradiolgamma-GlutamyltransferaseGrowth HormoneInsulin-Like Growth Factor IInsulin-Like Growth Factor IILevonorgestrelMineralocorticoid Receptor AntagonistsOsteocalcinPeptidesSex Hormone-Binding GlobulinTriglyceridesBone markersDrospirenoneEndocrinologyEstetrolLevonorgestrelLipid metabolismLiver function

Identifiers

PMID26212489
PMCPMC4699469
OpenAlexW1722228117

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.