| Methods |
66 sites in Denmark, Italy, New Zealand and the UK.
Six treatment cycles. Unblinded. |
| Participants |
Healthy women over 30 years of age with regular menses.
Excluded smokers over 34 years of age, select drug use, and lactation. |
| Interventions |
EE 20 µg and desogestrel 150 µg (N=501) versus EE 30 µg and gestodene 75 µg (N=505). |
| Outcomes |
Cycle control, discontinuation, body weight, blood pressure, and adverse events.
'Withdrawal' bleeding episode was defined as a sequence of one or more days of bleeding or spotting that began during the pill‐free period and was bounded by two consecutive days without bleeding. Results, though, were reported for 'irregular' bleeding (with and without withdrawal bleeding), which was never defined. |
| Notes |
Allocated with pre‐distributed schedules.
Excluded randomized women from the analysis.
87% (874/1006) completed study. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
Not reported |
