Over-the-counter pain medicine comparison for period cramps in women with Crohn's disease
Acetaminophen Versus Ibuprofen for Discomfort in Crohn's Disease (AVID-CD): An Open-Label Randomized Pilot Trial
This pilot will test whether ibuprofen or acetaminophen relieves period cramps more effectively and safely for women aged 18–44 who have Crohn's disease in remission.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | Female |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT07337902 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are people assigned female at birth, aged 18–44, with a confirmed Crohn's disease diagnosis who are in stable remission (CDAI <150), have regular menstrual cycles and primary dysmenorrhea, and are using reliable contraception or abstinence.
Not a fit: Those unlikely to benefit include people with active Crohn's disease, current pregnancy, other pelvic pathologies (for example endometriosis or fibroids), recent or unstable hormonal contraceptive use, or anyone outside the specified age or sex-at-birth criteria.
Why it matters
Potential benefit: If successful, the project could clarify which common over-the-counter pain medicine provides better period-cramp relief without worsening Crohn's disease, giving clearer guidance for symptom management.
How similar studies have performed: There is limited prior research directly comparing ibuprofen and acetaminophen for menstrual pain specifically in people with Crohn's disease, and concerns about NSAID effects on IBD make this a relatively novel and cautious pilot approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chapel Hill, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.