Davis 2005.
Methods | Randomisation list was prepared with random number tables. Double blind 76 participants randomised, 74 analysed. | |
Participants | Inclusion: aged 19 years or younger with moderate or severe dysmenorrhoea, regular menstrual cycles for at least 1 year, 21 to 35 days of menstrual cycle length, condom users. 300 adolescents were screened for eligibility. Exclusion: pregnancy, history of pelvic pathology, abnormal genital bleeding, recent miscarriage or abortion, use of other medications likely to interfere with metabolisms of oral contraceptives. Age: OC group: 16.7 +/‐ 2, Placebo group: 16.9 +/‐ 2 Source: medical centre, college campuses Location: USA | |
Interventions | 1. Ethinyl estradiol 0.02mg, 0.1mg levonorgestrel 2. Placebo Duration: 3 cycles | |
Outcomes | Pain severity (5 point scale)
Rating of worst pain intensity
Use of analgesic medication
Absence from work or study Adverse events Discontinuation rate |
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Notes | 3 publications from one study | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | Random numbers table |
Allocation concealment? | Low risk | A ‐ Adequate |
Blinding? All outcomes | Low risk | Double |
Incomplete outcome data addressed? All outcomes | Low risk | 76 randomised and 74 analysed |
Free of selective reporting? | Low risk | |
Power calculations | Low risk | Sample size was calculated for power to detect differences in main outcome of dysmenorrhoea between the OC group and the placebo group |
Dropouts reported | Low risk | 7/ 150 (4 from OCP and 3 from placebo group) |
Baseline comparability | Low risk |