| Methods |
Open‐label, randomized trial at one center in Denmark |
| Participants |
70 healthy women, 18 to 35 years. Inclusion criteria: desiring contraception for at least 13 cycles, new OC users or switchers with at least 2 OC‐free cycles before study.
Exclusion criteria: contraindications to OC use, parenteral depot contraceptive in past 6 months, co‐existing diseases (not specified in report), diagnostically unclassified genital bleeding, history of migraine with menstruation. |
| Interventions |
Levonorgestrel 100 µg + EE 20 µg (N=35) versus levonorgestrel 150 µg + EE 30 µg (N=35); 13 treatment cycles. |
| Outcomes |
Pregnancy and adverse events. |
| Notes |
No information on method of randomization.
Losses: 1 took no study medication (excluded) and 7 discontinued early (8/70 = 11%); no information about which groups these women were assigned to. Full analysis reportedly had N=69; 49 in per protocol analysis (22 in EE 20 µg group and 27 in 30 µg). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
Not reported |
