Methods |
One site in Italy.
Twelve treatment months. |
Participants |
Women age 18 to 43 years.
Excluded recent oral contraceptive or certain drug use; current cardiovascular or metabolic disease; agonistic activity. |
Interventions |
Desogestrel 150 µg and EE 20 µg versus gestodene 75 µg and EE 30 µg.
80 women randomized; initial number assigned to each study group not reported. |
Outcomes |
Weight, body composition changes. |
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 |
19 women discontinued early. Adverse events cited as primary reason for discontinuation were not described in detail.
No women were lost to follow up. |