An interventional study of Acetaminophen and Ibuprofen in Crohn's Disease (CD) and Dysmenorrhea Primary, sponsored by University of North Carolina, Chapel Hill. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 24 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive medications for each of four menstrual cycles in the following order: 1. Acetaminophen 2. Ibuprofen 3. Acetaminophen 4. Ibuprofen
Other: Acetaminophen · Other: Ibuprofen
Participants will receive medications for each of four menstrual cycles in the following order: 1. Acetaminophen 2. Ibuprofen 3. Ibuprofen 4. Acetaminophen
Other: Acetaminophen · Other: Ibuprofen
Participants will receive medications for each of four menstrual cycles in the following order: 1. Ibuprofen 2. Acetaminophen 3. Ibuprofen 4. Acetaminophen
Other: Acetaminophen · Other: Ibuprofen
Participants will receive medications for each of four menstrual cycles in the following order: 1. Ibuprofen 2. Acetaminophen 3. Acetaminophen 4. Ibuprofen
Other: Acetaminophen · Other: Ibuprofen
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.
Also known as: Tylenol
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.
Also known as: Advil
Proportion of Participants Who Express Interest in the Study Out of Those Contacted
Accrual will be determined as the 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
Proportion of participants who enroll out of those who expressed interest in the study
Accrual will be determined by the 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
Proportion of participants who meet the minimum adherence needed to contribute effectively to a subsequent study out of those randomized
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
Time frame: enrollment to completion of study, approximately 2.5 years
Number of Participants who meet exclusion criteria out ot the Total Screened
Recruitment Barriers will be determined among screened participants by the number who meet exclusion criteria
Time frame: first recruitment through screening, approximately 2 years
Reasons for Declining Study Participation by Category
Recruitment Barriers will be summarized by the number of participants among those eligible who have been screened listed by reason(s) for declining participation.
Time frame: first contact through screening, approximately 2 years
Number of Participants who consented that do not complete baseline visit
Recruitment Barriers will be summarized as the number of participants who consented that do not complete baseline visit
Time frame: first contact through end of study, approximately 2 years
Number of subjects who return all stool samples
Adherence Rates will be summarized as the number of subjects who return all stool samples
Time frame: enrollment through end of study, approximately 5 months
Number of participants who take the study drugs per protocol
Adherence Rates will be summarized by the number of participants who take the study drugs per protocol
Time frame: enrollment through end of study, approximately 5 months
Number of participants who complete the dysmenorrhea surveys
Adherence rates will be summarized by the number of participants who complete the dysmenorrhea surveys
Time frame: enrollment through end of study, approximately 5 months
Number of subjects who complete the Irritable Bowel Syndrome (IBD) surveys
Adherence Rates will be summarized by the number of subjects who complete the Irritable Bowel Syndrome (IBD) surveys
Time frame: enrollment through end of study, approximately 5 months
Number of subjects who complete all study activities per protocol
Adherence rates will be summarized by the number of subjects who complete all study activities per protocol
Time frame: enrollment through end of study, approximately 5 months
Number of participants who delay participation due to lack of dysmenorrhea
Adherence barriers will be summarized by the number of participants who delay participation due to lack of dysmenorrhea
Time frame: enrollment to end of study, approximately 5 months
Number of participants who delay participation or drop out due to active IBD
Adherence Barriers will be summarized by the number of participants who delay participation or drop out due to active IBD
Time frame: enrollment to end of study, approximately 5 months
Number of participants who use study drug for other indications during the study
Adherence Barriers will be summarized by number of participants who use study drug for other indications during the study
Time frame: enrollment to end of study, approximately 5 months
Number of participants who use a rescue medication
Adherence Barriers will be summarized by number of participants who use a rescue medication
Time frame: enrollment to end of study, approximately 5 months
Reported barriers to compliance with procedures
Participant qualitative interview feedback will be summarized by listing of reported barriers to compliance with procedures
Time frame: following completion of fourth menstrual cycle, single interview lasting approximately one hour
Acceptability of study intervention and protocol
Participant qualitative interview feedback will be summarized by number of participants reporting acceptability of study intervention and protocol
Time frame: following completion of fourth menstrual cycle, single interview lasting approximately one hour
Areas of confusion regarding instructions or protocol
Participant qualitative interview feedback will be summarized by a list of areas of confusion regarding instructions or protocol
Time frame: following completion of fourth menstrual cycle, single interview lasting approximately one hour
Interest in stool bio-banking for future research
Participant qualitative interview feedback will be summarized by number of subjects interested in stool bio-banking for future research
Time frame: following completion of fourth menstrual cycle, single interview lasting approximately one hour
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina.
Supporting information: Study protocol
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University of North Carolina, Chapel Hill