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01
Overview
Phase 4, randomised, double-blind trial of Aprol in primary dysmenorrhea (PD) (2 arms), sponsored by Bayer. Primary endpoint: Sum of Total Pain Relief. Started Apr 2018; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Naproxen Sodium : Acetaminophen
Aleve in Period 1, then Tylenol in Period 2
Acetaminophen : Naproxen Sodium
Tylenol in Period 1, then Aleve in Period 2
03
Who it enrols
Healthy female patients aged 15-35 with a history of primary dysmenorrhea and regular menstrual cycles, who typically use OTC analgesics for menstrual pain.
04
Endpoints
Primary
Sum of Total Pain Relief
Secondary
Summed Pain Intensity Difference
Sum of Total Pain Relief
Time to First Intake of Rescue Medication
Pain Intensity Difference
Global Evaluation Scores
Pain Relief Scores
05
Results
Primary endpoints met
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