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Cited by 57Reproductive Health and ContraceptionEstrogen and related hormone effectsMenopause: Health Impacts and Treatments

Estetrol combined with drospirenone: an oral contraceptive with high acceptability, user satisfaction, well-being and favourable body weight control

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Apter, Dan, Zimmerman, Yvette, Beekman, Louise, Mawet, Marie, Maillard, Catherine, Foidart, Jean-Michel, Coelingh Bennink, Herjan J. T.·2017·The European Journal of Contraception & Reproductive Health Care
DOI 10.1080/13625187.2017.1336532
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Abstract

OBJECTIVES: This study evaluated acceptability, user satisfaction, body weight control and general well-being of estetrol (E4) combined with either drospirenone (DRSP) or levonorgestrel (LNG). METHODS: In this open-label, multi-centre, dose-finding, 6-cycle study, 396 healthy women of reproductive age were randomised into five treatment groups in a 24/4-day regimen: 15 mg or 20 mg E4 combined with either 3 mg DRSP or 150 μg LNG, and as reference estradiol valerate (E2V) combined with dienogest (DNG). Data on acceptability, user well-being, satisfaction and body weight were collected. RESULTS: The number of completers was the highest in the 15 mg E4/DRSP group (91.1%), and the lowest for 20 mg E4/LNG (70.1%). The largest proportion of treatment satisfaction was reported for 15 mg E4/DRSP (73.1%), and the lowest for 15 mg E4/LNG (50.6%). The number of women willing to continue with the assigned study treatment was the highest in the 15 mg E4/DRSP group (82.1%) and the lowest for 20 mg E4/LNG (58.3%). Well-being with E4/DRSP combinations was statistically significantly better than with E4/LNG combinations: OR (95% CI) 2.00 (1.13; 3.53) and 1.93 (1.06; 3.56) for 15 and 20 mg E4, respectively, and comparable to E2V/DNG. Proportion of women with a 2 kg or more weight loss after 3 and 6 cycles was the highest in the 15 mg E4/DRSP group (30.7 and 36.7%, respectively). CONCLUSIONS: The present study shows that 15 mg estetrol combined with 3 mg DRSP is associated with a high-user acceptability and satisfaction, and with a favourable body weight control.

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  • E4 in combination with DRSP is associated with a favorable vaginal bleeding, safety and tolerability profile.

    “E4 in combination with DRSP inhibits ovulation and is associated with a favorable vaginal bleeding, safety and tolerability profile, and with high user satisfaction [ 9 , 12 , 13 ].”

    From Endocrine and metabolic effects of an oral contraceptive containing estetrol and drospirenone (2021) · cites this paper as [13]

    The Introduction reports that 15 mg E4/DRSP had the best bleeding and cycle control in the FIESTA study. The Acceptability of study medication section reports few discontinuations due to vaginal bleeding and adverse-event discontinuation rates, which offer limited evidence about tolerability. This paper does not establish the broader favourable safety profile claimed; its stated focus is acceptability, satisfaction, well-being and body weight. (LLM, conf=0.86)

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  • E4 in combination with DRSP inhibits ovulation.

    “E4 in combination with DRSP inhibits ovulation and is associated with a favorable vaginal bleeding, safety and tolerability profile, and with high user satisfaction [ 9 , 12 , 13 ].”

    From Endocrine and metabolic effects of an oral contraceptive containing estetrol and drospirenone (2021) · cites this paper as [13]

  • E4 in combination with DRSP is associated with high user satisfaction.

    “E4 in combination with DRSP inhibits ovulation and is associated with a favorable vaginal bleeding, safety and tolerability profile, and with high user satisfaction [ 9 , 12 , 13 ].”

    From Endocrine and metabolic effects of an oral contraceptive containing estetrol and drospirenone (2021) · cites this paper as [13]

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Research works printed but not linked: 1

  1. World Health Organization. Medical eligibility criteria for contra- ceptive use. 4th ed. Geneva, Switzerland: WHO Press; 2009. p. 15-44.

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Authors
Apter, D., Zimmerman, Y., Beekman, L., Mawet, M., Maillard, C., Foidart, J.-M., & Coelingh Bennink, H. J. T.
Affiliations
  • Väestöliitto (FI)
  • Pantarhei Bioscience (Netherlands) (NL)
  • Estetra SPRL, Liège, Belgium;
  • University of Liège (BE)
  • Pantarhei Bioscience BV, Zeist, the Netherlands;
Corresponding author
Mawet, Marie
ORCID
Venue
The European Journal of Contraception & Reproductive Health Care
Publisher
Informa UK Limited
Published
2017-06-22
Volume
22
Issue
4
Pages
260-267
ISSN
  • 1362-5187 (ISSN-L)
  • 1473-0782
DOI
10.1080/13625187.2017.1336532
OpenAlex
W2659286080
Cited by
57
References
30
Citations by year
2026: 6 · 2025: 6 · 2024: 9 · 2023: 9 · 2022: 6 · 2021: 14 · 2020: 5 · 2019: 2
FWCI
1.80
Type
journal article
Language
en
Open access
Licence
Locations
  • The European Journal of Contraception & Reproductive Health Care (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • ORBi (University of Liège) (submittedVersion, other-oa)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Reproductive Health and Contraception
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Estrogen and related hormone effects
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
Keywords
estetrol, drospirenone, levonorgestrel, oral contraceptives, acceptability, user satisfaction, well-being, weight management, weight loss, estradiol valerate, dienogest, dose-finding, women of reproductive age
MeSH terms
Adolescent, Adult, Mineralocorticoid Receptor Antagonists, Androstenes, Body Weight, Contraceptives, Oral, Combined, Contraceptives, Oral, Hormonal, Estetrol, Female, Finland, Humans, Surveys and Questionnaires, Uterine Hemorrhage, Patient Satisfaction, Young Adult, Intention to Treat Analysis

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