Recruiting

Ibuprofen & Acetaminophen

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07337902

Conditions

Crohn's Disease (CD)

Dysmenorrhea Primary

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Not accepted

Interventions

Acetaminophen

Ibuprofen

Study Details

Brief summary:

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

Crohn's Disease (CD)

Dysmenorrhea Primary

Study ID

NCT07337902

Start date

Mar 18, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ages 18-44 years
  • Assigned female at birth
  • Crohn's Disease (CD) diagnosis
  • In stable clinical remission from CD, defined as a short Crohn's Disease Activity Index (CDAI; See Table 3) <150 without use of corticosteroids
  • Self-reported primary dysmenorrhea
  • Regular menstrual cycles occurring every 23-35 days
  • Using an appropriate contraceptive method or abstinence

Exclusion Criteria:

  • 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 pregnancy
  • Plans to become pregnant during the study period
  • 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 trial
  • Taking hormone therapy including estrogen or progesterone that is not part of a hormonal contraceptive
  • Known hypersensitivity or contraindication to ibuprofen or acetaminophen
  • Inability to complete REDCap questionnaires (including confusion despite training and/or lack of smart phone and/or computer access).
  • Not able to speak and read English language.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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

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

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

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

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.

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.

Primary outcome measure

  • 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 [ 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 [ Time Frame: enrollment to completion of study, approximately 2.5 years ]

Central Contacts and Locations

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Rachel Cooke, MS

919-964-2141rachel_cooke@med.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • Crohn's Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-07-14.