At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 201 enrolled
Drug / intervention
Naproxen Sodium, (Aleve, BAY117031) +1 moredrug
Likely dose
Naproxen Sodium, (Aleve, BAY117031) 220 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Randomized, Crossover Study to Assess Menstrual Cramp Pain Associated With Primary Dysmenorrhea
In Brief
A Phase 4 clinical trial evaluating Naproxen Sodium, (Aleve, BAY117031) and Acetaminophen (Tylenol Extra Strength) for Dysmenorrhea. Completed, enrolled 201 participants across 8 sites.
Detailed Summary
The purpose of this study is to compare the maximum single dose of Aleve® (two tablets, equivalent to 440 mg of naproxen sodium) to the maximum single dose of Tylenol Extra Strength (two caplets, equivalent to 1000 mg of acetaminophen) in the treatment of menstrual pain associated with primary dysmenorrhea.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDysmenorrhea
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedFeb 2018
Enrollment StartApr 2018
Primary CompletionSep 2018
TodayJul 2026
First PostedFeb 28, 2018
Enrollment StartApr 5, 2018
Primary CompletionSep 5, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.3 years ago
Interventions
Naproxen Sodium, (Aleve, BAY117031)drug
220 mg \*2 tablets, orally, single dose
Acetaminophen (Tylenol Extra Strength)drug
500 mg \*2 caplets, orally, single dose