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Compares treatment options for Crohn's Disease (CD)
Official title Comparing Over the Counter Pain Medicines for Discomfort in Crohn's Disease (AVID-CD)
ClinicalTrials.gov ID: NCT07337902
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 44, women only
You may be able to join if
- 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
You likely can't join if
- Any of the following conditions: endometriosis, adenomyosis, polycystic ovarian syndrome, endometrial fibroids/polyps, chronic pelvic inflammatory...
- 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...
- 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).
See the full eligibility 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
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 44 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.