A Study to Assess Menstrual Cramp Pain Associated With Primary Dysmenorrhea

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:
• Abstinence for at least the last 60 days AND willingness to use double barrier method should the patient become sexually active during the study;
• Double barrier method (condom with contraceptive foam, diaphragm with contraceptive gel);
• Permanent sterilization of patient or her spouse/partner;
• Oral contraceptive (must have been using the same oral contraceptive for at least three months prior to study entry and agrees to remain on the same type and method throughout the course 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

• Patient has a known history of allergic, idiosyncratic or serious adverse reaction, to acetaminophen, naproxen, aspirin, ibuprofen, or any other nonsteroidal anti-inflammatory drug (NSAID);
• Patient has a known allergy to any of the excipients in any of the study medication products;
• Patient has experienced asthma, urticaria, or allergic-type reactions after taking aspirin, acetaminophen or other NSAIDs;
• Patient has significant co-existing illness, including gastrointestinal, hepatic, renal, neurologic, cardiovascular, psychiatric, endocrine, respiratory, surgical procedure or other condition that, in the Investigator's judgment, contraindicates administration of the study medication;
• Patient has a current or past history of severe gastritis, gastrointestinal bleeding or ulceration;
• Patient has a current or past history of one or more of the following conditions: secondary dysmenorrhea, pelvic inflammatory disease, urinary tract infection (currently acute or recurrent [defined as more than three per year] prior history of an urinary tract infection is eligible for enrollment), adnexal masses, uterine fibroids, endometriosis, adenomyosis that in the opinion of the Investigator would impact patient safety and/or the study data;
• Patient has an ongoing sexually transmitted disease (except for a history of genital herpes or Human Papillomavirus) or has abnormal vaginal discharge;
• Patient requires prescription analgesics, narcotic, non-NSAID (i.e., defined as oral use of 5 or more times per week for greater than 3 weeks) or has routinely taken OTC medications in excess of label recommended instructions for control of dysmenorrh