A Study to Assess Menstrual Cramp Pain Associated With Primary Dysmenorrhea
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Intervention: Naproxen Sodium, (Aleve, BAY117031); Acetaminophen (Tylenol Extra Strength)
Intervention description: 220 mg *2 tablets, orally, single dose; 500 mg *2 caplets, orally, single dose
Intervention MeSH terms: Acetaminophen; Naproxen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 201.0
Sex: Female
Minimum age: 15 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: Primary dysmenorrhea of at least moderate severity

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.
    

Eligibility criteria:

        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 dysmenorrhea
             symptoms;

          -  Patient is taking mood-altering agents (e.g., antidepressants, sedatives,
             phenothiazines, or anti-anxiety agents). Patients who are on a stable dose for at
             least 3 months, and not taking this medication for dysmenorrhea or premenstrual
             syndrome are eligible for enrollment;

          -  Patient does not agree to abstain from taking any analgesic and/or anti-inflammatory
             medication (with the exception of low dose aspirin [defined as no greater than 100 mg
             daily] taken for cardioprotective purposes) approximately 72 hours prior to the
             anticipated treatment period and throughout the dosing/assessment period. All pain and
             anti-inflammatory medications including supplements, topical heat or cold, and other
             products of topical application will be discontinued approximately 72 hours prior to
             the anticipated dosing for each treatment period and throughout the dosing/assessment
             period;

          -  Patient does not agree to abstain from using transcutaneous electrical nerve
             stimulation devices that are used to treat dysmenorrhea throughout each treatment
             period;

          -  Patient is taking piroxicam (Feldene®) or oral corticosteroids. Patients taking
             inhaled or topical corticosteroids are eligible for enrollment;

          -  Patient is pregnant, lactating , or less than 6 months postpartum;

          -  Patient is currently using an intra-uterine devices (IUD), or using hormonal implants
             (e.g., Norplant) or injections (e.g., Depo-Provera) for contraception or used within
             the past 6 months;

          -  Patient is currently using an oral contraceptive for less than 3 months, has been on a
             unstable dose within the last 3 months or has switched from one oral contraceptive to
             another within the last 3 months or intends to do so in the course of the study;

          -  Patient has a history of chronic abuse of alcohol (regularly consumes 3 or more
             alcoholic drinks per day), analgesics, narcotic analgesics, ergot alkaloids,
             tranquilizers, or opioids or other substances known to produce dependence; in the
             judgement of the investigator within the past 3 years;

          -  Positive drug at screening and visit 2 for illegal drug substances, or non-prescribed
             controlled substances;

          -  Positive pregnancy test or breast feeding at screening and prior to dosing in each
             Treatment Period;

          -  Patients with a medical disorder, condition or history such that could impair the
             patient's ability to participate or complete this study in the opinion of the
             investigator.