Crohn's Disease (CD) · Dysmenorrhea Primary
Acetaminophen Versus Ibuprofen for Period Cramps in Crohn's Disease
This randomized pilot study is testing whether a larger comparison of acetaminophen and ibuprofen is practical among adults with Crohn's disease and primary period cramps.
Registry title: Comparing Over the Counter Pain Medicines for Discomfort in Crohn's Disease (AVID-CD)
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years–44 Years
- Treatment
- Acetaminophen or Ibuprofen
- Design
- Randomized
- Sponsor
- University of North Carolina, Chapel Hill
Research question
Can researchers feasibly recruit and retain participants and complete the medication, sample, and survey activities needed for a larger study comparing acetaminophen with ibuprofen?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 to 44 who were assigned female at birth.
- The study is looking for people diagnosed with Crohn's disease who are in stable clinical remission without corticosteroids.
- The study is looking for people who report primary period cramps and have menstrual cycles every 23 to 35 days.
- The listed recruiting location is the University of North Carolina at Chapel Hill.
Participation overview
What participation may involve
After an in-person screening visit, participants complete four menstrual-cycle periods at home using acetaminophen and ibuprofen in a randomized order, provide stool samples, answer electronic surveys, and complete a final remote interview. What participation may involve: - Attend a screening visit with a blood draw, physical examination, pregnancy test, stool testing, and surveys about Crohn's disease and menstrual cycles. - Take the assigned medication three times daily for three days after period cramps begin in each of four menstrual cycles. - Provide a stool sample before each menstrual cycle and another after each three-day medication period. - Complete brief electronic surveys before each cycle, while experiencing cramps, and after each medication period. - Complete a remote feedback interview after the fourth menstrual cycle; an outcome entry describes this interview as lasting approximately one hour. Participation spans four menstrual cycles, and several outcome entries describe enrollment through study completion as approximately five months; another outcome entry inconsistently states approximately 2.5 years. The registry describes one screening visit, home-based activities afterward, and one remote interview following the fourth menstrual cycle.
Study interventions
What participants may receive or do
- Acetaminophen: Participants take 650 mg of oral acetaminophen three times daily for three days after cramps begin during two of four menstrual cycles.
- Ibuprofen: Participants take 400 mg of oral ibuprofen three times daily for three days after cramps begin during two of four menstrual cycles.
Study design
How the comparison works
This is an open-label crossover pilot study: every participant receives both medications during four menstrual cycles, with the medication sequence assigned at random. Participants are randomly assigned to one of four sequences that determine which medication they take during each menstrual cycle. The study has no masking, so participants know which medication they are taking. There is no separate control group; each participant receives acetaminophen during two cycles and ibuprofen during two cycles.
Reported activities
Procedures and tests
- A blood draw is included at the screening visit.
- A physical examination is included at the screening visit.
- A pregnancy test is included at the screening visit.
- Stool testing is included at screening, followed by stool samples before and after each menstrual-cycle medication period.
- Participants complete electronic surveys about Crohn's disease, menstrual cycles, and cramps.
- Participants complete a remote qualitative interview after the fourth menstrual cycle.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be ages 18 to 44.
- Participants must have been assigned female at birth.
- A Crohn's disease diagnosis is required.
- Crohn's disease must be in stable clinical remission, defined as a short Crohn's Disease Activity Index below 150 without corticosteroid use.
- Participants must report primary period cramps.
- Menstrual cycles must occur regularly every 23 to 35 days.
- Participants must use an appropriate contraceptive method or practice abstinence.
Possible reasons someone may not be able to join
- The study excludes people with any listed pelvic condition, a history of pelvic surgery including hysterectomy, or a current pregnancy.
- People planning to become pregnant during the study period are excluded.
- Oral contraceptive use must have been stable for at least three months, without a recent switch or plans to switch during the trial.
- Hormone therapy containing estrogen or progesterone is excluded unless it is part of a hormonal contraceptive.
- People with a known allergy or other contraindication to ibuprofen or acetaminophen are excluded.
- Participants must be able to complete REDCap questionnaires, including having smartphone or computer access and understanding the questionnaires after training.
- Participants must be able to speak and read English.
Important unknowns
What the record does not make clear
- The study description covers four menstrual cycles and several outcomes state approximately five months, but one primary outcome states that enrollment through study completion is approximately 2.5 years.
- The record does not explain whether participants continue their usual Crohn's disease medicines during the study.
- The record does not state whether participants must avoid or stop other pain medicines before or during study medication periods.
- The outcomes track rescue-medication use, but the record does not identify permitted rescue medicines or when they may be taken.
- The record does not describe study-related costs, medication charges, or insurance billing.
- The record does not state whether participants are compensated.
- The record does not state whether transportation, parking, or other travel support is available for screening.
- The record does not state that an endoscopy is required or explain how stable Crohn's disease remission will be confirmed.
Before contacting the site
Questions for the study team
- How long should one participant expect to be in the study from screening through the final interview?
- How will the study team confirm stable Crohn's disease remission, and is an endoscopy required?
- Which usual Crohn's disease treatments and other pain medicines may be continued during the study?
- What rescue medication may be used if cramps continue during a three-day medication period?
- How are stool samples collected, stored, and returned from home?
- Are there participant costs, insurance charges, compensation, or travel support?
Before changing care
Questions for your gastroenterologist
- Does my current Crohn's disease status fit the study's definition of stable clinical remission?
- Could either ibuprofen or acetaminophen pose concerns given my Crohn's disease, medical history, and current medicines?
- Would any of my current treatments need to change, and what approved alternatives are available if a change is proposed?
- How should my gastroenterology care and monitoring be coordinated with the research team during the study?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- University of North Carolina, Chapel Hill
- Organization class
- Other
- Organization study ID
- 24-2940
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Crossover
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult
Study arms
Experimental
Acetaminophen, Ibuprofen, Acetaminophen, Ibuprofen
Participants will receive medications for each of four menstrual cycles in the following order: 1. Acetaminophen 2. Ibuprofen 3. Acetaminophen 4. Ibuprofen
Interventions: Other: Acetaminophen, Other: Ibuprofen
Experimental
Acetaminophen, Ibuprofen, Ibuprofen, Acetaminophen
Participants will receive medications for each of four menstrual cycles in the following order: 1. Acetaminophen 2. Ibuprofen 3. Ibuprofen 4. Acetaminophen
Interventions: Other: Acetaminophen, Other: Ibuprofen
Experimental
Ibuprofen, Acetaminophen, Ibuprofen, Acetaminophen
Participants will receive medications for each of four menstrual cycles in the following order: 1. Ibuprofen 2. Acetaminophen 3. Ibuprofen 4. Acetaminophen
Interventions: Other: Acetaminophen, Other: Ibuprofen
Experimental
Ibuprofen, Acetaminophen, Acetaminophen, Ibuprofen
Participants will receive medications for each of four menstrual cycles in the following order: 1. Ibuprofen 2. Acetaminophen 3. Acetaminophen 4. Ibuprofen
Interventions: Other: Acetaminophen, Other: Ibuprofen
Interventions
Other
Acetaminophen
Participants will receive oral acetaminophen 650 mg three times daily for three days during two of four menstrual cycles by random assignment at the onset of cramps.
Other
Ibuprofen
Participants will receive oral ibuprofen 400 mg three times daily for three days during two of four menstrual cycles by random assignment at the onset of cramps.
Eligibility
18 Years–44 Years
Female
Not accepted
Inclusion criteria (7)
- Ages 18-44 yearsRegistry-derived · unreviewed
- Assigned female at birthRegistry-derived · unreviewed
- Crohn's Disease (CD) diagnosisRegistry-derived · unreviewed
- In stable clinical remission from CD, defined as a short Crohn's Disease Activity Index (CDAI; See Table 3) \<150 without use of corticosteroidsRegistry-derived · unreviewed
- Self-reported primary dysmenorrheaRegistry-derived · unreviewed
- Regular menstrual cycles occurring every 23-35 daysRegistry-derived · unreviewed
- Using an appropriate contraceptive method or abstinenceRegistry-derived · unreviewed
Exclusion criteria (7)
- 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 pregnancyRegistry-derived · unreviewed
- Plans to become pregnant during the study periodRegistry-derived · unreviewed
- 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 trialRegistry-derived · unreviewed
- Taking hormone therapy including estrogen or progesterone that is not part of a hormonal contraceptiveRegistry-derived · unreviewed
- Known hypersensitivity or contraindication to ibuprofen or acetaminophenRegistry-derived · unreviewed
- Inability to complete REDCap questionnaires (including confusion despite training and/or lack of smart phone and/or computer access).Registry-derived · unreviewed
- Not able to speak and read English language.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Proportion of Participants Who Express Interest in the Study Out of Those Contacted
Time frame: from first contact to informed consent, up to 2 years
Accrual will be determined as the proportion of participants who express interest in the study out of those contacted
Primary outcome
Proportion of participants who enroll out of those who expressed interest in the study
Time frame: from first contact to informed consent, up to 2 years
Accrual will be determined by the proportion of participants who enroll out of those who expressed interest in the study
Primary outcome
Proportion of participants who meet the minimum adherence needed to contribute effectively to a subsequent study out of those randomized
Time frame: enrollment to completion of study, approximately 2.5 years
Protocol Adherence will be determined by the proportion of participants who meet the minimum adherence needed to contribute effectively to a subsequent study out of those randomized
Secondary outcome
Number of Participants who meet exclusion criteria out ot the Total Screened
Time frame: first recruitment through screening, approximately 2 years
Recruitment Barriers will be determined among screened participants by the number who meet exclusion criteria
Secondary outcome
Reasons for Declining Study Participation by Category
Time frame: first contact through screening, approximately 2 years
Recruitment Barriers will be summarized by the number of participants among those eligible who have been screened listed by reason(s) for declining participation.
Secondary outcome
Number of Participants who consented that do not complete baseline visit
Time frame: first contact through end of study, approximately 2 years
Recruitment Barriers will be summarized as the number of participants who consented that do not complete baseline visit
Secondary outcome
Number of subjects who return all stool samples
Time frame: enrollment through end of study, approximately 5 months
Adherence Rates will be summarized as the number of subjects who return all stool samples
Secondary outcome
Number of participants who take the study drugs per protocol
Time frame: enrollment through end of study, approximately 5 months
Adherence Rates will be summarized by the number of participants who take the study drugs per protocol
Secondary outcome
Number of participants who complete the dysmenorrhea surveys
Time frame: enrollment through end of study, approximately 5 months
Adherence rates will be summarized by the number of participants who complete the dysmenorrhea surveys
Secondary outcome
Number of subjects who complete the Irritable Bowel Syndrome (IBD) surveys
Time frame: enrollment through end of study, approximately 5 months
Adherence Rates will be summarized by the number of subjects who complete the Irritable Bowel Syndrome (IBD) surveys
Secondary outcome
Number of subjects who complete all study activities per protocol
Time frame: enrollment through end of study, approximately 5 months
Adherence rates will be summarized by the number of subjects who complete all study activities per protocol
Secondary outcome
Number of participants who delay participation due to lack of dysmenorrhea
Time frame: enrollment to end of study, approximately 5 months
Adherence barriers will be summarized by the number of participants who delay participation due to lack of dysmenorrhea
Secondary outcome
Number of participants who delay participation or drop out due to active IBD
Time frame: enrollment to end of study, approximately 5 months
Adherence Barriers will be summarized by the number of participants who delay participation or drop out due to active IBD
Secondary outcome
Number of participants who use study drug for other indications during the study
Time frame: enrollment to end of study, approximately 5 months
Adherence Barriers will be summarized by number of participants who use study drug for other indications during the study
Secondary outcome
Number of participants who use a rescue medication
Time frame: enrollment to end of study, approximately 5 months
Adherence Barriers will be summarized by number of participants who use a rescue medication
Secondary outcome
Reported barriers to compliance with procedures
Time frame: following completion of fourth menstrual cycle, single interview lasting approximately one hour
Participant qualitative interview feedback will be summarized by listing of reported barriers to compliance with procedures
Secondary outcome
Acceptability of study intervention and protocol
Time frame: following completion of fourth menstrual cycle, single interview lasting approximately one hour
Participant qualitative interview feedback will be summarized by number of participants reporting acceptability of study intervention and protocol
Secondary outcome
Areas of confusion regarding instructions or protocol
Time frame: following completion of fourth menstrual cycle, single interview lasting approximately one hour
Participant qualitative interview feedback will be summarized by a list of areas of confusion regarding instructions or protocol
Secondary outcome
Interest in stool bio-banking for future research
Time frame: following completion of fourth menstrual cycle, single interview lasting approximately one hour
Participant qualitative interview feedback will be summarized by number of subjects interested in stool bio-banking for future research
Recruiting locations in the United States
University of North Carolina at Chapel Hill
RecruitingChapel Hill, North Carolina, 27599, United States
Rachel Cooke, MS919-964-2141rachel_cooke@med.unc.edu
Registry dates
- First posted
- Jan 13, 2026
- Primary completion
- Jul 2028
- Overall completion
- Jul 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.