Treatment of menstrual cramps in young adult women— randomized controlled trial of standard versus experimental dosing of ibuprofen
Primary dysmenorrhea (menstrual cramps)
Participants are randomized to intensive or standard ibuprofen dosing for the treatment of menstrual cramps (primary dysmenorrhea). Experimental (intense ibuprofen dosing) - Their prescription will read “Following the initial 400 mg dose with food/milk, take another 200 mg tablet with food/milk as soon as cramps start to return, even if this is only 1-2 hours since the last dose, to a maximum of 12 tabs every 24 hours.” Standard (recommended Ibuprofen for cramps dosing) – Their prescription will read “Following the initial 400 mg dose with food/milk, take another 200 mg tablet with food/milk every 4-6 hours to a maximum of 12 tabs every 24 hours.” The study duration per participant will be up to 16 days, with 1 day of screening and enrolment, 7 premenstrual days and 7 menstrual cycle days for independent data collection, and 1-2 days for follow-up and completing a final questionnaire.
Current inclusion criteria as of 04/02/2026: Resident within Metro Vancouver with access to offices in the Diamond Centre near Vancouver General Hospital 1. Menstruating individuals 16-35 years of age 2. Regular menstrual cycles, approximately 1 month apart (range 21-35 days or 3-5 weeks) 3. Moderate to severe cramps (problematic cramps) interfering with daily life and activities (as defined by the screening questionnaire) 4. If sexually active with a man, may be using non-hormonal contraceptives (condoms, diaphragm either or both with vaginal spermicide, or the copper IUD) Previous inclusion criteria: Resident within Metro Vancouver with access to offices in the Diamond Centre near Vancouver General Hospital 1. Menstruating individuals 16-25 years of age 2. Regular menstrual cycles, approximately 1 month apart (range 21-35 days or 3-5 weeks) 3. Moderate to severe cramps (problematic cramps) interfering with daily life and activities (as defined by the screening questionnaire) 4. If sexually active with a man, may be using non-hormonal contraceptives (condoms, diaphragm either or both with vaginal spermicide, or the copper IUD)
1. Hormonal contraceptives (including combined hormonal contraceptives, levonorgestrel-releasing IUDs*, hormonal implant, Depo-Provera, progestin-only pill) and emergency contraceptives within the last cycle, or any reproductive hormone use within the last 3 months. 2. Have inability to take or should not take Ibuprofen as described by the screening questionnaire. For example, a hypersensitivity to Ibuprofen or other NSAIDs or any ingredients in the formulation of the Ibuprofen tablets, which may include microcrystalline cellulose, croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, hydroxypropyl cellulose, polyethylene glycol, titanium dioxide, D&C yellow #10 and FD&C yellow #6, carnauba wax. 3. Have complete or partial syndrome of acetylsalicylic acid (ASA) intolerance (rhinosinusitis, urticaria/angioedema, nasal polyps, asthma) in whom asthma, anaphylaxis, urticaria/angioedema, rhinitis or other allergic manifestations are precipitated by ASA or other NSAIDs, as per the contraindications section in the manufacturer product monograph. 4. Active gastric or duodenal ulcer, a history of recurrent ulceration, gastrointestinal bleeding, or active inflammatory disease of the gastrointestinal system. Patients with gastroesophageal reflux disease (GERD) are not excluded by these criteria. 5. Significant hepatic impairment or active liver disease. 6. History of severe kidney disease defined as eGFR <30ml/min. 7. Have suffered from an acute kidney injury (serum creatinine rise of 26 uM) in the past 6 weeks due to significant fluid loss. 8. Have systemic lupus erythematosus, as anaphylaxis-type reactions with fever have been documented to occur when Ibuprofen has been administered previously, as per the contraindication’s sections in the manufacturer product monograph. 9. Endometriosis (by history, imaging or surgery). 10. Pregnant or postpartum for less than 6 weeks. *Note: If we run into difficulty recruiting enough participants, we will consider incl