ArticleThe Journal of clinical endocrinology and metabolism2022
Low Thrombin Generation in Users of a Contraceptive Containing Estetrol and Drospirenone.
Article in The Journal of clinical endocrinology and metabolism, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02957630 (A Single Center, Randomized,Open-label,Controlled, Three-arm Study to Evaluate the Effect of a New Combined Oral Contraceptive), which is not on this map. Cited by 17 papers, 3 of them syntheses that pooled it.
What it found
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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.
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.
A Single Center, Randomized,Open-label,Controlled, Three-arm Study to Evaluate the Effect of a New Combined Oral Contraceptive (COC) Containing 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP) and of Two Reference COCs Containing Either 30 mcg Ethinylestradiol (EE) and 150 mcg Levonorgestrel (LNG) or 20 mcg EE and 3 mg DRSP on Endocrine Function, Metabolic Control and Hemostasis During 6 Treatment Cycles
Who cites it
17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 34 citations in OpenAlex.
- Estetrol-based combined oral contraceptives: A systematic review of clinical outcomes.Acta obstetricia et gynecologica Scandinavica · 2026Pooled it
- Estetrol/drospirenone for combined oral contraception: a systematic review of efficacy, cycle control, and safety.Frontiers in endocrinology · 2026Pooled it
- Are natural estrogens used in contraception at lower risk of venous thromboembolism than synthetic ones? A systematic literature review and meta-analysis.Frontiers in endocrinology · 2024Pooled it
- Effects of estetrol/drospirenone vs drospirenone-only on thrombin generation in women with polycystic ovary syndrome: a randomized, double-blind, controlled trial.Research and practice in thrombosis and haemostasis · 2026Trial
- Impact of Estetrol Combined with Drospirenone on Blood Coagulation and Fibrinolysis in Patients with Endometriosis: A Multicenter, Randomized, Open-Label, Active-Controlled, Parallel-Group Study.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisTrial
- A detailed review of pharmacokinetics/pharmacodynamics of progestogens in oral contraception.Frontiers in endocrinology · 2026Review
- Estetrol and its implications for contraception, venous thromboembolism, and breast cancer: an integrative review.Jornal vascular brasileiro · 2026Review
- The impact of protein S and tissue factor pathway inhibitor on coagulation, assessed with thrombin generation, in women starting combined oral contraceptives.Research and practice in thrombosis and haemostasis · 2025Article
- Update on long- and short-acting contraceptive methods.Australian prescriber · 2025Review
- The effect of combined oral contraceptives on thrombin generation assessed on ST Genesia- a paired clinical study.Thrombosis journal · 2025Article
- Cost-effective screening strategy to prevent venous thromboembolism in combined oral contraceptive users.Frontiers in endocrinology · 2025Article
- Chapter 3. Impact of estrogens on hemostasis.Frontiers in endocrinology · 2025Review
- Proposal for targeted, neo-evolutionary-oriented secondary prevention of early-onset endometriosis and adenomyosis. Part II: medical interventions.Human reproduction (Oxford, England) · 2024Article
- The benefits of estetrol addition to drospirenone for contraception.AJOG global reports · 2023Article
- Estetrol Is Safe and Well Tolerated during Treatment of Hospitalized Men and Women with Moderate COVID-19 in a Randomized, Double-Blind Study.Journal of clinical medicine · 2023Article
- Estetrol: From Preclinical to Clinical Pharmacology and Advances in the Understanding of the Molecular Mechanism of Action.Drugs in R&D · 2023Review
- Response to paper by BinkowskaPrzeglad menopauzalny = Menopause review · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo compare the impact on thrombin generation of the new combined oral contraceptive containing 15 mg estetrol and 3 mg drospirenone with ethinylestradiol (30 or 20 mcg) associated either with 150 mcg levonorgestrel or with 3 mg drospirenone.
methodsData were collected from the "E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study" (NCT02957630). Overall, the per-protocol set population included 24 subjects in the ethinylestradiol/levonorgestrel arm, 28 subjects in the ethinylestradiol/drospirenone arm, and 34 subjects in the estetrol/drospirenone arm. Thrombograms and thrombin generation parameters (lag time, peak, time to peak, endogenous thrombin potential, and mean velocity rate index) were extracted for each subject at baseline and after 6 cycles of treatment.
resultsAfter 6 cycles of treatment, ethinylestradiol-containing products arms show a mean thrombogram outside the upper limit of the reference range, that is the 97.5th percentile of all baseline thrombograms. On the other hand, the mean thrombogram of estetrol/drospirenone is within this reference interval. After 6 cycles of treatment, all thrombin generation parameters are statistically less affected by estetrol/drospirenone than ethinylestradiol-containing products.
conclusionsIn conclusion, an association of 15 mg estetrol with 3 mg drospirenone does not have an impact on thrombin generation compared with ethinylestradiol-containing products that, either associated with levonorgestrel or drospirenone, are able to increase the production of procoagulant factors and decrease the production of anticoagulant ones, shifting the patient to a prothrombotic state. Ethinylestradiol-containing products thus generate prothrombotic environments contrary to estetrol which demonstrates a neutral profile on hemostasis.
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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.