| Methods |
Randomisation method not stated.
Open trial
1563 participants randomised which included women with no dysmenorrhoea.
Withdawals: 449(228 from gestodene group and 221 from desogestrel group) |
| Participants |
Inclusion: aged 18 to 35 years old, desire for contraception for at least 12 months
Exclusion: contraindications to OC use, various pathologies, unclassified genital bleeding, history of migraine accompanying menstrual bleeding, pregnancy.
Age: GSD group ‐ 25.5, DSG group ‐ 25.1
Location: France, Austria, United Kingdom, the Netherlands, Switzerland and Italy. |
| Interventions |
1. Ethinyl estradiol 0.02mg, 0.15mg desogestrel
2. Ethinyl estradiol 0.02mg, 0.075mg gestodene
Duration: 12 cycles |
| Outcomes |
Dysmenorrhoea (did or did not experience pain relief) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
No information provided |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
| Blinding?
All outcomes |
High risk |
Open |
| Incomplete outcome data addressed?
All outcomes |
High risk |
87 women were excluded from the analysis because of protocol violations |
| Free of selective reporting? |
Unclear risk |
Did not report adverse events |
| Power calculations |
Low risk |
|
| Dropouts reported |
Low risk |
449/1563 (228 from gestodene group and 221 from desogestrel group) |
| Baseline comparability |
Low risk |
|
