Oddsson 2005.
Methods | Randomized trial in 11 countries in Europe and South America. | |
Participants | 1030 healthy women, 18 or more years old Exclusion criteria: contraindication to hormonal contraception, injectable contraceptive use in past 6 months, postpartum or postabortion in past 2 months, breastfeeding in past 2 months, abnormal cervical smear in screening, or drugs that interfere with contraceptive metabolism. | |
Interventions | Vaginal ring releasing etonogestrel 120 µg + EE 15 µg daily (N=512) versus COC containing levonorgestrel 150 µg + EE 30 µg (N=518); 13 treatment cycles. |
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Outcomes | Contraceptive efficacy, compliance, safety, cycle control. Subjects used diary cards to record ring or pill use; data used to determine exposure and compliance. |
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Notes | Corresponding investigator provided bleeding data. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization conducted with interactive voice response system, which gave treatment group and medication number. |
Allocation concealment (selection bias) | Low risk | interactive voice response system |
Blinding (performance bias and detection bias) All outcomes | High risk | open label |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss after randomization and before treatment: 1079 ‐1030 = 49 Loss after treatment = 298/1030 = 29%; ring 29% and COC 29% Total loss = (49 + 298) /1079 = 32%; ring 33% and COC 31% |