Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07337902
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
44 Years
Study:
NCT07337902
Study Brief:
Protocol Section:
NCT07337902