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Estetrol and Drospirenone
Estetrol and drospirenone work together as a hormonal contraceptive, with estetrol providing estrogenic activity and drospirenone providing progestagenic activity to prevent ovulation.
Estetrol and drospirenone work together as a hormonal contraceptive, with estetrol providing estrogenic activity and drospirenone providing progestagenic activity to prevent ovulation. Used for Contraception in women of reproductive age.
At a glance
| Generic name | Estetrol and Drospirenone |
|---|---|
| Sponsor | Ospedale Policlinico San Martino |
| Drug class | Combined oral contraceptive |
| Target | Estrogen receptor; progesterone receptor |
| Modality | Small molecule |
| Therapeutic area | Contraception |
| Phase | FDA-approved |
Mechanism of action
Estetrol is a natural estrogen produced during pregnancy that acts as an estrogen receptor agonist, while drospirenone is a progestin with antimineralocorticoid properties. Together they suppress the luteinizing hormone (LH) and follicle-stimulating hormone (FSH) surges needed for ovulation, and alter cervical mucus and endometrial conditions to prevent fertilization and implantation.
Approved indications
- Contraception in women of reproductive age
Common side effects
- Headache
- Nausea
- Breast tenderness
- Breakthrough bleeding
- Mood changes
Key clinical trials
- International Active Surveillance Study: Safety of Estrogen Estetrol (E4) Contraceptive Study (INAS-SEECS)
- International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study
- Prospective Evaluation on the Role Exerted by Hormonal Contraceptives on 24-h Blood Pressure. A Prospective Observational Study
- "Quick-starting" of a New Combined Hormonal Contraceptive Pills, 15 mg Estetrol/3 mg Drospirenone VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition (NA)
- Estetrol/Drospirenone to Reduce the Average Size of Endometriomas (PHASE4)
- The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation (PHASE4)
- The Use of Drospirenone/Estetrol in Random Start Rapid Endometrial Preparation (PHASE4)
- Safety, Compliance and Pharmacokinetics of Estetrol Monohydrate/Drospirenone 15/3 mg in Post-menarchal Female Adolescents (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Estetrol and Drospirenone CI brief — competitive landscape report
- Estetrol and Drospirenone updates RSS · CI watch RSS
- Ospedale Policlinico San Martino portfolio CI