Evidence map›Paper›PMID 26394847›Full record

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

Inhibition of ovulation by administration of estetrol in combination with drospirenone or levonorgestrel: Results of a phase II dose-finding pilot study.

Ingrid J M Duijkers, Christine Klipping, Yvette Zimmerman, Nicole Appels, Maud Jost, Catherine Maillard, Marie Mawet, Jean-Michel Foidart, Herjan J T Coelingh Bennink

Open access · hybridAbstract readClinical Trial, Phase II
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 18 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 4 pooled it
5.1field-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.

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

18 citing papers in PubMed, 4 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. Review
  14. Progestogen-only oral contraceptives.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2022
    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. Article
  18. 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

9 authors at 3 institutions in 2 countries.

Ingrid J M Duijkersa * Dinox BV , Groningen , the Netherlands.
Christine Klippinga * Dinox BV , Groningen , the Netherlands.
Yvette Zimmermanb Pantarhei Bioscience BV , Zeist , the Netherlands.
Nicole Appelsb Pantarhei Bioscience BV , Zeist , the Netherlands.
Maud Jostc Estetra SPRL , Liège , Belgium.
Catherine Maillardc Estetra SPRL , Liège , Belgium.
Marie Mawetc Estetra SPRL , Liège , Belgium.
Jean-Michel Foidartc Estetra SPRL , Liège , Belgium.
Herjan J T Coelingh Benninkb Pantarhei Bioscience BV , Zeist , the Netherlands.
University of Liège · BEPantarhei Bioscience (Netherlands) · NLDialyse Centrum Groningen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe aim of the study was to evaluate the efficacy of different dosages of estetrol (E4) combined with one of two progestins in suppressing the pituitary-ovarian axis and ovulation in healthy premenopausal women.

methodsThis was an open, parallel, phase II, dose-finding, pilot study performed in healthy women aged 18 to 35 years with a documented ovulatory cycle before treatment. For three consecutive cycles in a 24/4-day regimen, participants received 5 mg or 10 mg E4/3 mg drospirenone (DRSP); 5 mg, 10 mg or 20 mg E4/150 μg levonorgestrel; or 20 μg ethinylestradiol (EE)/3 mg DRSP as comparator. Pituitary-ovarian axis activity and the occurrence of ovulation were evaluated by monitoring follicular size, serum levels of follicle-stimulating hormone, luteinising hormone, estradiol and progesterone during treatment cycles 1 and 3. Endometrial thickness was evaluated throughout the trial, and the return of ovulation was evaluated after the last intake of medication.

resultsA total of 109 women were included in the trial. No ovulation occurred in any treatment group. Ovarian activity inhibition seemed proportional to the E4 dosage: the highest suppression was observed in the 20 mg E4 group and was very similar to that observed with EE/DRSP. Endometrial thickness was suppressed to the same extent in all groups. Post-treatment ovulation occurred in all participants between 17 and 21 days after the last active treatment. The study combinations were well tolerated and safe.

conclusionsCombined with a progestin, E4 adequately suppresses ovarian activity, particularly when given at a dosage above 10 mg/day.

Indexed as

Ovulation InhibitionAdolescentAdultAndrostenesContraceptives, Oral, CombinedDose-Response Relationship, DrugEndometriumEstetrolEstradiolEthinyl EstradiolFemaleFollicle Stimulating HormoneHumansLevonorgestrelLuteinizing HormoneMineralocorticoid Receptor AntagonistsAndrostenesContraceptives, Oral, CombineddrospirenoneEstetrolEstradiolEthinyl EstradiolFollicle Stimulating HormoneLevonorgestrelLuteinizing HormoneMineralocorticoid Receptor AntagonistsProgesteroneEstetrolEstrogenOral contraceptionOvulation inhibitionProgestin

Identifiers

PMID26394847
PMCPMC4673580
OpenAlexW1889867145

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.