| Methods |
123 sites in France, Austria, the UK, The Netherlands, Switzerland and Italy.
12 treatment cycles. |
| Participants |
Healthy women age 18 to 35 years with regular menses.
Excluded current use of oral contraceptive containing 150 µg desogestrel and 20 µg EE; contraindications to oral contraceptive use; recent depot‐contraceptives use; unclassified genital bleeding; excessive smoking. |
| Interventions |
Gestodene 75 µg and EE 20 µg (N=786) versus desogestrel 150 µg and EE 20 µg (N=777). |
| Outcomes |
Contraceptive efficacy, cycle control, adverse events. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No information |
| Allocation concealment (selection bias) |
Unclear risk |
No information |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Unblinded |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
228 women in the gestodene and 221 women in the desogestrel group discontinued early or were lost to follow up. Primary reasons for discontinuation described and did not include weight gain.
87 women were excluded from analysis for protocol violations. |
