Status and phase
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Study type
Funder types
Identifiers
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Ambulatory healthy female patients between 15 and 35 years of age;
Patient has a history of Over-the-Counter (OTC) analgesic use for treatment of primary dysmenorrhea;
Patient has a history of regular menstrual cycles that typically occurs between every 21 to 35 days;
Patient has a self-reported history of primary dysmenorrhea (onset <5 years after menarche) with at least moderate menstrual cramp pain (based on the categorical pain intensity scale, 0-3) occurring during four of the past six menstrual cycles;
Patient has a self-reported history of primary dysmenorrhea with other causes of dysmenorrhea having been excluded;
Patient typically requires at least one dose of an OTC analgesic medication such as naproxen, aspirin, acetaminophen, or ibuprofen taken on at least 1 day of her menstrual cycle for the treatment of moderate or severe menstrual cramp, and normally experiences pain relief from these medications;
Patient is of child-bearing potential and is using one of the following methods of contraception and agrees to continue this same method for the duration of the study:
Patient is willing to participate in the study and return to the study site within approximately 1 week after her menstrual cycle to return the study medication, urine pregnancy test, and for review of the completed patient e-diary;
Patient is willing to abstain from alcohol consumption throughout the 12-hour Treatment Period;
Patient is willing to abstain from caffeine consumption throughout the 12-hour Treatment Period;
Patient is willing to ingest the overencapsulated tablets throughout the study;
Patient is willing and able to participate in all scheduled visits, treatment plan, laboratory tests and other study procedures according to the clinical protocol.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
201 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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