| Methods |
Randomisation by 'envelope method'
Double blind
22 participants randomised, 18 analysed |
| Participants |
Inclusion: severe primary dysmenorrhoea that required absence from duty
Location: Japan |
| Interventions |
1. SH‐850 ‐ 0.5mg norgestrel, 0.05mg ethinyl estradiol from day 5‐25
2. Placebo
Duration: 44 cycles experimental group, 31 cycles placebo group (between 3‐6 cycles for each participant) |
| Outcomes |
Degree of symptomatic relief ‐ 3 point scale for each women and cycle
Menstrual flow |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
No data provided |
| Allocation concealment? |
Low risk |
A "envelope method" |
| Blinding?
All outcomes |
Low risk |
Double |
| Incomplete outcome data addressed?
All outcomes |
High risk |
|
| Free of selective reporting? |
Unclear risk |
No adverse events |
| Power calculations |
High risk |
|
| Dropouts reported |
Low risk |
4/22 |
| Baseline comparability |
Low risk |
|
