Pilot Study Comparing Ibuprofen and Acetaminophen for Period Cramp Relief in Women with Crohns Disease

What this Trial Is About

Researchers are evaluating two common pain medications, ibuprofen and acetaminophen, to see how they help treat period cramps in women with Crohns disease. This pilot study aims to prepare for a larger trial by identifying challenges in participation, adherence to the study plan, and completion of study activities. The study focuses on women aged 18 to 44 who have Crohns disease and experience primary dysmenorrhea with regular menstrual cycles. Participants will be randomly assigned to take either ibuprofen 400 mg three times daily or acetaminophen 650 mg three times daily for three days during their menstrual cramps. Each participant will take both medications over four menstrual cycles, with each medication taken for two cycles in a randomized order. The order of medication use varies for different groups. Study medication intake and stool sample collection will be done at home. Participants will undergo an initial screening visit including a blood draw, physical exam, pregnancy test, stool testing, and surveys about Crohns disease and menstrual cycles. Before each menstrual cycle, participants submit a stool sample and complete a brief electronic survey. During cramps, they take the assigned medication and fill out short surveys. After medication use, they submit another stool sample and complete more surveys. After four cycles, participants will have a remote interview to provide feedback. The study tracks interest, enrollment, adherence, and completion rates over about 2.5 years.

Comparing Over the Counter Pain Medicines for Discomfort in Crohn's Disease (AVID-CD)