Effects of estetrol/drospirenone versus ethinyl estradiol/drospirenone on glucose tolerance in women with polycystic ovary syndrome: A randomised controlled trial
Authors' conclusion
E4/DRSP was not inferior to EE/DRSP in its effects on glucose tolerance, insulin levels and HOMA-IR, supporting its use as a potential oral contraceptive option in women with PCOS.
Study context
- Population
- Women with polycystic ovary syndrome (PCOS) (modified 2003 Rotterdam criteria); 2-month washout between regimens61 completed both phases
- Participants
- 66 women
- Comparison
- E4/DRSP vs EE/DRSP
- Primary endpoint
- Glucose tolerance (75 g OGTT)
Methodological detailsopen-label, crossover, Conducted January 2024 to January 2025
- Open-label
- Crossover
- Conducted January 2024 to January 2025
Primary result
As reported in the abstract
Mean change in 2-h OGTT glucose
E4/DRSP
4.65
mean · 95% CI −2.37–11.66 · mg/dL
EE/DRSP
14.40
mean · 95% CI 7.50–21.29 · mg/dL
P = 0.05
Further findings
| Outcome | E4/DRSP | EE/DRSP | P value |
|---|---|---|---|
| Mean change in 1-h insulin levelsNo significant difference · μU/mL | −1.04 (95% CI −25.94–23.86) | −0.77 (95% CI −25.24–23.70) | P = 0.99 |
| Mean change in HOMA-IRNo significant difference | 0.28 (95% CI −0.24–0.80) | 0.60 (95% CI 0.09–1.11) | P = 0.39 |
- Mean change in 1-h insulin levels: upper boundary for non-inferiority margin of 50.72
- Mean change in homeostatic model assessment for insulin resistance (HOMA-IR): upper boundary for non-inferiority margin of 1.06
Original publication
Effects of estetrol/drospirenone versus ethinyl estradiol/drospirenone on glucose tolerance in women with polycystic ovary syndrome: A randomised controlled trial. Diabetes Obes Metab. Published 12 September 2025. doi:10.
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