Over-the-counter pain medicine comparison for period cramps in women with Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot enrolls people assigned female at birth, ages 18–44, with Crohn's disease in stable clinical remission and self-reported primary dysmenorrhea. Participants complete a screening visit with a blood draw, pregnancy test, stool testing, a physical exam, and questionnaires, then continue the rest of the study at home. They will be assigned to take either ibuprofen or acetaminophen for four menstrual cycles and asked to submit samples and complete surveys. Investigators will track feasibility outcomes including recruitment, adherence to the medication plan, retention through the study, and completion of study activities to inform a larger trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ages 18-44 years
* Assigned female at birth
* Crohn's Disease (CD) diagnosis
* In stable clinical remission from CD, defined as a short Crohn's Disease Activity Index (CDAI; See Table 3) \<150 without use of corticosteroids
* Self-reported primary dysmenorrhea
* Regular menstrual cycles occurring every 23-35 days
* Using an appropriate contraceptive method or abstinence

Exclusion Criteria:

* Any of the following conditions: endometriosis, adenomyosis, polycystic ovarian syndrome, endometrial fibroids/polyps, chronic pelvic inflammatory disease, a history of pelvic surgery including hysterectomy, any other pathological pelvic conditions, or current pregnancy
* Plans to become pregnant during the study period
* Use of an oral contraceptive for less than 3 months, on an unstable oral contraceptive dose within the last 3 months, switched from one oral contraceptive to another within the last 3 months or intend to do so during the course of the trial
* Taking hormone therapy including estrogen or progesterone that is not part of a hormonal contraceptive
* Known hypersensitivity or contraindication to ibuprofen or acetaminophen
* Inability to complete REDCap questionnaires (including confusion despite training and/or lack of smart phone and/or computer access).
* Not able to speak and read English language.

Where it's running

• University of North Carolina at Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Erica J Brenner, MD, MSCR — University of North Carolina, Chapel Hill

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.