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