Actively Recruiting

Phase Not Applicable
Age: 18Years - 44Years
FEMALE
NCT07337902

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

Led by University of North Carolina, Chapel Hill · Updated on 2026-03-23

24

Participants Needed

1

Research Sites

119 weeks

Total Duration

On this page

Sponsors

U

University of North Carolina, Chapel Hill

Lead Sponsor

A

American College of Gastroenterology

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this pilot study is to prepare for a larger study that will compare the effectiveness and safety of two common pain medications, ibuprofen and acetaminophen, to help treat period cramps in women with Crohn's disease. The goal of this study is to identify any challenges in running a larger study. The investigators will track how many people sign up for the study, how well participants follow the study plan, how many people stay in the study, and whether they are able to complete all the study activities, such as taking the medication, submitting samples, and filling out surveys. During the study, participants will undergo a screening visit that includes a blood draw, physical exam, pregnancy test, stool testing, and complete surveys about Crohn's disease and menstrual cycles. Once this visit is complete, the rest of the study will occur at home. Participants will be assigned to take either ibuprofen or acetaminophen to help treat period cramps for four menstrual cycles in a row. Participants will take ibuprofen for two cycles and acetaminophen for two cycles. Participants will know which medication is being taken at any given time, but the order in which they take the medications will be randomly assigned. Before each menstrual cycle, participants will submit a stool sample and fill out a short (\<1 minute) electronic survey. When participants develop period cramps, they will take the assigned medication for three days and fill out short (\<1 minute) electronic surveys about their cramps. After participants finish taking the medication for three days, they will submit another stool sample and fill out two more short (\<1 minute) electronic surveys. After have completing this process for four menstrual cycles, a remote interview with a researcher to give feedback on the study will be conducted.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 44Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 18-44 years
  • Assigned female at birth
  • Diagnosed with Crohn's Disease
  • Stable clinical remission from Crohn's Disease without corticosteroids
  • Self-reported primary dysmenorrhea
  • Regular menstrual cycles every 23-35 days
  • Using appropriate contraception or abstinent
Not Eligible

You will not qualify if you...

  • Conditions including endometriosis, adenomyosis, polycystic ovarian syndrome, endometrial fibroids/polyps, chronic pelvic inflammatory disease, pelvic surgery history, other pelvic conditions, or current pregnancy
  • Plans to become pregnant during the study
  • Oral contraceptive use unstable or less than 3 months, or planned changes within the study
  • Taking hormone therapy not part of contraception
  • Known allergy or contraindication to ibuprofen or acetaminophen
  • Inability to complete electronic questionnaires due to confusion or lack of device access
  • Unable to read and speak English

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

4

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