Primary dysmenorrhea (menstrual cramps) Urological and Genital Diseases
Conditions
Interventions
Participants are randomized to intensive or standard ibuprofen dosing for the treatment of menstrual cramps (primary dysmenorrhea).
Experimental (intense ibuprofen dosing) - Their prescription will r
Sponsors
Centre for Menstrual Cycle and Ovulation Research
Eligibility
Sex/Gender
Female
Age
16 Years to 35 Years
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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 including individuals with regular cycles (i.e., approximately 1 month apart) over the last 3 months, who have worn Kyleena for 60 days or Mirena for 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The perceived change (scored -5, 0, +5) in cramp intensity on intensive ibuprofen dosing (experimental) versus standard-of-care ibuprofen dosing both as compared with usual cramp experience in the last 3 months, as recorded in the Final Questionnaire at the end of each volunteer’s participation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Variables relevant to participants’ cramp experience: changes in feeling of self-worth, feeling of energy and outside stresses recorded before and during flow, as scored on a scale from 1-5, as recorded by a daily Menstrual Cycle Diary© (Daily Diary) throughout the 14 days of this study 2. Amount of flow as recorded on the Daily Diary by number of soaked tampons +/- pads (normal size-soaked/day), or by volume scoring if they are using a menstrual cup 3. Gastrointestinal ibuprofen adverse effects: heartburn, stomach pain, nausea, vomiting, as recorded on the daily Ibuprofen Therapy Recording form during cramps 4. General menstrual flow or cramps adverse effects (headache, tiredness, diarrhea, sleep problems) recorded on the Daily Diary and the Ibuprofen Therapy Recording form throughout the trial and during cramps, respectively 5. Total mg of ibuprofen/day taken for menstrual cramps recorded using the daily Ibuprofen Therapy Recording form over each of the 1st to 7th menstrual cycle days 6. Remaining ibuprofen pill counts by random assignment (returning them to the participant) at the end of each volunteer’s trial participation 7. Mean menstrual cramp intensity scored on a scale from 0-4, by the Daily Diary during the time of experiencing cramps 8. Mean menstrual cramp duration as recorded >0 in the Daily Diary during the time of experiencing cramps 9. Cramps Score = (total days with cramps X mean cramp intensity), by prospective daily Menstrual Cycle Diary© records during the time of experiencing cramps 10. Perceived change in the duration of cramps on the Final Questionnaire at each volunteer’s end of participation 11. Perceived change in the impact of cramps on daily life as reported on the Final Questionnaire at each volunteer’s end of participation | — |
Countries
Canada
Contacts
Public ContactJerilynn Prior
Outcome results
None listed