Table 1

Trial details

Trial ID
Study drug and dose, number of women
Design
Observations after 8 hrs
Quality score
Validity score

38
49 women
Rofecoxib 25 mg
Rofecoxib 50 mg
Ibuprofen 400 mg
Placebo
Single oral dose, parallel 3 menstrual cycles
12, 24
5/5
≥13/16
55
60 women
Rofecoxib 50 mg then 25 mg as required
Naproxen sodium 550 mg every 12 hrs
Placebo
Oral. Multiple dose study with single dose efficacy data, multiple dose adverse events Cross-over, 1 of 6 drug sequences 3 menstrual cycles
12 hour obervations after a single dose in a three-day study
5/5
≥13/16
56
122 women
Rofecoxib 50 mg as required
Rofecoxib 50 mg then 25 mg as required
Naproxen sodium 550 mg every 12 hrs
Placebo
Oral. Multiple dose study with single dose efficacy data, multiple dose adverse events Cross-over, 1 of 4 drug sequences 4 menstrual cycles
12 hour obervations after a single dose in a three-day study
5/5
≥13/16

Edwards et al. BMC Women's Health 2004 4:5   doi:10.1186/1472-6874-4-5