Skip to main content
. 2009 Oct 7;2009(4):CD002120. doi: 10.1002/14651858.CD002120.pub3

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
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