Methods |
Two sites in Germany.
Six treatment cycles. |
Participants |
Women age 18 to 35 years with regular menses.
Excluded contraindications for oral contraceptive use; recent hormonal drugs. |
Interventions |
Dienogest 2 mg and EE 30 µg versus dienogest 2 mg and EE 20 µg versus dienogest 2 mg, estradiol valerate 2 mg and EE 10 µg versus levonorgestrel 100 µg and EE 20 µg.
100 women randomized; initial number assigned to each study group not reported. |
Outcomes |
Lipid metabolism. |
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 |
Low risk |
"Double‐blinded" but did not report who was blinded. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
110 women screened and 100 randomized.
Eight women discontinued early. Primary reasons for discontinuation not described.
One woman lost to follow up.
Intent‐to treat analysis used. |