Drospirenone and estetrol

(Nextstellis®)

Nextstellis®

Drug updated on 5/17/2024

Dosage FormTablet (oral; drospirenone/estetrol 3 mg/14.2 mg)
Drug ClassProgestin and estrogen
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for use by females of reproductive potential to prevent pregnancy.

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Summary
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  • Drospirenone and estetrol (Nextstellis) is indicated for use by females of reproductive potential to prevent pregnancy. It has demonstrated high contraceptive efficacy with low pregnancy rates among users, as evidenced by Pearl Index scores ranging from 0.47 to 2.65 pregnancies per 100 woman-years in sexually active women aged between 18-50 years.
  • Four randomized controlled studies provided comprehensive data on Nextstellis's effectiveness across different subgroups including various age groups, body mass indexes, previous contraceptive use, and racial backgrounds.
  • The safety profile of drospirenone and estetrol (Nextstellis) was found to be favorable with most adverse events being mild to moderate such as headache, abnormal bleeding, vaginal hemorrhage, and acne; severe adverse events like venous thromboembolism were notably low compared to other hormonal contraceptives.
  • Discontinuation rates due to adverse effects ranged from a relatively low percentage of 7.1% to 9.1%, suggesting that the drug's tolerability is generally good; specific concerns leading to discontinuation included heavy menstrual bleeding, but these instances were uncommon overall.
  • A predictable bleeding pattern was observed in the majority of women using drospirenone and estetrol (Nextstellis), along with a significant decrease in unscheduled bleeding/spotting episodes over time which can contribute positively towards user satisfaction and compliance.
  • Drospirenone and estetrol (Nextstellis) presents an efficacy profile comparable or superior to other available combined oral contraceptives, making it a competitive option especially considering its lower associated risks for serious side effects like thrombosis.

Product Monograph / Prescribing Information

Document TitleYearSource
Nextstellis (drospirenone and estetrol) Prescribing Information.2023Mayne Pharma, Greenville, NC

Randomized Controlled Trials


Sex Distribution:

F:100%
M:0%
1553Subjects

Year:

2022

Source:An International Journal of Obstetrics and Gynaecology


Sex Distribution:

F:100%
M:0%
4422Subjects

Year:

2022

Source:Contraception


Sex Distribution:

F:100%
M:0%
1674Subjects

Year:

2021

Source:Contraception