| Methods |
Random ‐ unstated
Double blind, parallel trial
40 participants randomised |
| Participants |
Inclusion: severe primary dysmenorrhoea (incapacitating pain for 2 or more days per cycle), pelvic exam to confirm no pathology.
Exclusion: mild pain, dysmenorrhoea due to organic causes
Age: groups 1 and 2 ‐ average 20; group 3 ‐ average 22
Location: USA |
| Interventions |
1. Norinyl 2 ‐ norethindrone 2mg with mestranol 0.1mg from day 5 to 25 (equivalent to 70mcg of ethinyl oestradiol)
2. Sequential regimen with mestranol 0.08mg from day 5 for 11 days then chlormadinone acetate 2mg added for last 10 days of cycle. (This is equivalent to 56 mcg of ethinyl oestradiol)
3. Placebo ‐ day 5 to 25
Duration: 3 cycles |
| Outcomes |
Duration and severity of dysmenorrhoea ‐ measured pre, during and post. No adverse events were collected. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
No method stated |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear, stated randomised |
| Blinding?
All outcomes |
Low risk |
Double blind |
| Incomplete outcome data addressed?
All outcomes |
Unclear risk |
No data provided |
| Free of selective reporting? |
Unclear risk |
No data provided |
| Power calculations |
Unclear risk |
No data provided |
| Dropouts reported |
Unclear risk |
No data provided |
| Baseline comparability |
Unclear risk |
No data provided |
