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Drospirenone / Estetrol
Drospirenone / Estetrol is a Combined oral contraceptive Small molecule drug developed by University of Palermo. It is currently FDA-approved for Contraception in women of childbearing age.
Drospirenone and estetrol work together as a hormonal contraceptive by suppressing ovulation through progestin and estrogen activity.
Drospirenone and estetrol work together as a hormonal contraceptive by suppressing ovulation through progestin and estrogen activity. Used for Contraception in women of childbearing age.
At a glance
| Generic name | Drospirenone / Estetrol |
|---|---|
| Sponsor | University of Palermo |
| Drug class | Combined oral contraceptive |
| Target | Progesterone receptor, estrogen receptor |
| Modality | Small molecule |
| Therapeutic area | Contraception / Women's Health |
| Phase | FDA-approved |
Mechanism of action
Drospirenone is a fourth-generation progestin with antimineralocorticoid and antiandrogenic properties that inhibits the LH surge necessary for ovulation. Estetrol is a natural estrogen metabolite that provides estrogenic support while maintaining a favorable safety profile. Together they prevent pregnancy through multiple mechanisms including ovulation suppression, cervical mucus thickening, and endometrial changes.
Approved indications
- Contraception in women of childbearing 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:
- Drospirenone / Estetrol CI brief — competitive landscape report
- Drospirenone / Estetrol updates RSS · CI watch RSS
- University of Palermo portfolio CI
Frequently asked questions about Drospirenone / Estetrol
What is Drospirenone / Estetrol?
How does Drospirenone / Estetrol work?
What is Drospirenone / Estetrol used for?
Who makes Drospirenone / Estetrol?
What drug class is Drospirenone / Estetrol in?
What development phase is Drospirenone / Estetrol in?
What are the side effects of Drospirenone / Estetrol?
What does Drospirenone / Estetrol target?
Related
- Drug class: All Combined oral contraceptive drugs
- Target: All drugs targeting Progesterone receptor, estrogen receptor
- Manufacturer: University of Palermo — full pipeline
- Therapeutic area: All drugs in Contraception / Women's Health
- Indication: Drugs for Contraception in women of childbearing age
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing