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

Open Data