Drospirenone/estetrol

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Drospirenone/estetrol
Combination of
DrospirenoneProgestogen
Estetrol (medication)Estrogen
Clinical data
Trade namesNextstellis, others
Other namesE4/DRSP; FSN-013
AHFS/Drugs.comMonograph
License data
Pregnancy
category
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Identifiers
ChemSpider
  • None
KEGG

Drospirenone/estetrol, sold under the brand name Nextstellis among others, is a fixed-dose combination medication containing drospirenone, a progestin, and estetrol, an estrogen, which is used as a combined birth control pill for the prevention of pregnancy in women.[2][4] It is taken by mouth.[2][4]

It was approved for medical use in Canada in March 2021,[3] and in the United States in April 2021.[4]

Medical uses[]

Drospirenone/estetrol is used as a combined birth control pill to prevent pregnancy in women.[2][4]

Pharmacology[]

Pharmacodynamics[]

Drospirenone/estetrol has a much lower impact on liver protein synthesis, including of sex hormone-binding globulin, angiotensinogen, and coagulation factors, than does ethinylestradiol/drospirenone.[7]

Society and culture[]

Legal status[]

Drospirenone/estetrol is approved for the use of hormonal contraception in the European Union,[5][6] the United States,[8] and Canada.[3]

Brand names[]

Available forms[]

Drospirenone/estetrol in sold under the brand names Nexstellis, Drovelis, and Lydisilka.

See also[]

  • Birth control pill formulations
  • List of combined sex-hormonal preparations § Estrogens and progestogens

References[]

  1. ^ a b "Nextstellis". Therapeutic Goods Administration (TGA). 6 December 2021. Retrieved 28 December 2021.
  2. ^ a b c d https://pdf.hres.ca/dpd_pm/00060352.PDF
  3. ^ a b c "Nextstellis Product information". Health Canada. 25 April 2012. Retrieved 4 November 2021.
  4. ^ a b c d e "Nextstellis- drospirenone and estetrol kit". DailyMed. Retrieved 1 June 2021.
  5. ^ a b "Drovelis EPAR". European Medicines Agency (EMA). Retrieved 4 November 2021.
  6. ^ a b "Lydisilka EPAR". European Medicines Agency (EMA). Retrieved 4 November 2021.
  7. ^ Farris M, Bastianelli C, Rosato E, Brosens I, Benagiano G (October 2017). "Pharmacodynamics of combined estrogen-progestin oral contraceptives: 2. effects on hemostasis". Expert Rev Clin Pharmacol. 10 (10): 1129–1144. doi:10.1080/17512433.2017.1356718. PMID 28712325. S2CID 205931204.
  8. ^ "Drug Approval Package: Nextstellis". U.S. Food & Drug Administration (FDA). 12 May 2021. Retrieved 30 November 2021.

External links[]

  • "Drospirenone". Drug Information Portal. U.S. National Library of Medicine.
  • "Estetrol". Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT02817828 for "E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - EU/Russia Study" at ClinicalTrials.gov
  • Clinical trial number NCT02817841 for "E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - United States/Canada Study" at ClinicalTrials.gov


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