Cure8 trial brief
Why This Matters
People with Crohn's disease commonly experience menstrual cramps, but there is little trial evidence comparing common OTC pain medicines in this group. This pilot trial aims to test whether a larger randomized study is feasible and acceptable.
Who Should Pay Attention
Adult patients with Crohn's disease who get menstrual cramps, clinicians who manage IBD care in reproductive-age patients, and researchers planning trials about symptom management in IBD.
Study Snapshot
What To Know
This listing is a small, University of North Carolina–run pilot trial testing over-the-counter pain medicines (ibuprofen and acetaminophen) for menstrual cramps in people with Crohn's disease. Participants will take each medicine for two menstrual cycles over four cycles total; the order is randomly assigned and not blinded.
The study focuses on feasibility outcomes — sign-up rates, adherence, retention, and study-process tasks like at-home stool samples and short electronic surveys — to inform a larger future trial. Screening visits include blood tests, pregnancy testing, stool testing, a physical exam, and baseline surveys; most study activities occur remotely.
Eligibility is limited to people assigned female at birth ages 18–44 with Crohn's disease in stable remission and primary dysmenorrhea, and excludes several gynecologic conditions and pregnancy. Treatments are standard OTC doses given for three days per cycle at the onset of cramps.
Participants and clinicians considering enrollment should review the full ClinicalTrials.gov record and discuss individual risks, especially given that NSAIDs like ibuprofen can have specific safety considerations in people with IBD.
Keep In Mind
This is a pilot/feasibility interventional study (recruiting) with planned enrollment of 24. It tests short-term, commonly used OTC doses of ibuprofen and acetaminophen and emphasizes feasibility metrics rather than clinical efficacy outcomes. NSAID safety in IBD is an important consideration; consult clinical guidance and the trial protocol for details.
Source Details
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.