Drug updated on 3/28/2024
| Dosage Form | Tablet (oral; drospirenone/estetrol 3 mg/14.2 mg) |
| Drug Class | Contraceptives |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for use by females of reproductive potential to prevent pregnancy.
Summary
- Drospirenone and estetrol (Nextstellis) is indicated for use by females of reproductive potential to prevent pregnancy.
- Two randomized controlled trials were reviewed, providing information on the contraceptive efficacy, bleeding pattern, safety profile and tolerability of Nextstellis.
- The first trial was a multicenter phase 3 study conducted across sixty-nine sites in Europe and Russia involving sexually active women aged 18-50 years with regular menstrual cycles and body mass index ≤35 kg/m².
- This trial found that Nextstellis provides effective contraception with a Pearl Index (PI) of 0.47 pregnancies/100 woman-years; method failure PI was 0.29 pregnancies/100 woman-years indicating its high contraceptive efficacy compared to other drugs.
- In terms of safety profile from both studies, common adverse events included headache, metrorrhagia (heavy periods), vaginal haemorrhage and acne; one treatment-related serious adverse event reported was lower extremity venous thromboembolism while discontinuation due to treatment-related AEs occurred in about 8% participants mainly due to bleeding complaints or mood disturbance.
- Overall findings suggest that drospirenone and estetrol (Nextstellis) has a predictable bleeding pattern along with favorable tolerability making it an effective option for preventing pregnancy among females of reproductive age group as per these two randomized controlled trials data analysis results.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Nextstellis (drospirenone and estetrol) Prescribing Information. | 2023 | Mayne Pharma, Greenville, NC |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Estetrol-drospirenone combination oral contraceptive: a clinical study of contraceptive efficacy, bleeding pattern and safety in europe and russia. | 1,553Subjects F: 100% M: 0% | 2022 | An International Journal of Obstetrics and Gynaecology |
| Tolerability and safety of the estetrol/drospirenone combined oral contraceptive: Pooled analysis of two multicenter, open-label phase 3 trials. | 3,417Subjects F: 100% M: 0% | 2022 | Contraception |
Sex Distribution:
F:100%
M:0%
1553Subjects
Year:
2022
Source:An International Journal of Obstetrics and Gynaecology
Sex Distribution:
F:100%
M:0%
3417Subjects
Year:
2022
Source:Contraception