Drospirenone/estetrol

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][6] It is taken by mouth.[2][6]

Drospirenone/estetrol
Combination of
DrospirenoneProgestogen
Estetrol (medication)Estrogen
Clinical data
Trade namesNextstellis, Drovelis, Lydisilka, 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

It was approved for medical use in Canada in March 2021,[3] and in the United States in April 2021.[6]

Medical uses

Drospirenone/estetrol is used as a combined birth control pill to prevent pregnancy in women.[2][6]

Side effects

Estetrol-containing birth control pills, similarly to estradiol-containing birth control pills, may have a lower risk of venous thromboembolism (VTE) than ethinylestradiol-containing birth control pills based on studies of coagulation.[11][12] However, it is likely that another decade will be required before post-marketing epidemiological studies of VTE incidence with these birth control pills are completed and able to confirm this.[13]

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.[14]

Society and culture

Drospirenone/estetrol is approved for the use of hormonal contraception in the European Union,[7][8] the United States,[15] and Canada.[3]

Brand names

Drospirenone/estetrol in sold under the brand names Nexstellis,[3] Drovelis,[7] and Lydisilka.[8]

See also

References

  • 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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