| Methods |
Randomisation list was generated by computer.
Open trial
1027 women initially randomised, 239 dropouts (unacceptable bleeding problems, adverse events).
349 of the initial group randomised had dysmenorrhoea and no dropouts reported. |
| Participants |
Inclusion: aged 18 to 45 years old, BMI of 18 to 29 kg/m2
Exclusion: smoking, concomitant medication or addictive drugs, psychiatric disorders, using injectable hormonal contraceptives within 6 months of enrolment
Age: DSG group ‐ 28.2, LNG group ‐ 28.5
Location: Germany and the Netherlands |
| Interventions |
1. Ethinyl estradiol 0.02mg and 0.15mg desogestrel
2. Ethinyl estradiol 0.02mg and 0.01mg levonorgestrel
Treatment was for 6 months and 5 months follow up |
| Outcomes |
Dysmenorrhoea (improved/ not improved) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Computer generated |
| Allocation concealment? |
Unclear risk |
B ‐ |
| Blinding?
All outcomes |
High risk |
Open |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
|
| Free of selective reporting? |
Unclear risk |
No adverse events reported |
| Power calculations |
High risk |
|
| Dropouts reported |
Low risk |
239/1027 |
| Baseline comparability |
Low risk |
|
