Status:
COMPLETED
Dysmenorrhea in Women With Crohn's Disease and Ulcerative Colitis
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Crohn's Disease
Ulcerative Colitis
Eligibility:
FEMALE
18-48 years
Brief Summary
This case-control study will screen for dysmenorrhea and assess severity of menstrual symptoms in menstruating women with CD and UC compared with healthy age-matched controls. IBD activity will be cha...
Detailed Description
Given the prior studies in IBD and corollary studies in IBS, we hypothesize that dysmenorrhea is more common in menstruating women with CD and UC than in the general population. Furthermore, we hypoth...
Eligibility Criteria
Inclusion
- Inclusion criteria.
- Cases: Women aged 18-48 years with regular menstrual cycles AND with an established diagnosis of CD or UC involving the small bowel, colon or both will be eligible for the study. Cases may be using oral, transdermal, or intravaginal hormonal contraception for the purpose of birth control. Regular menstrual cycles will be defined as cycles ranging from of 24 to 35 days and lasting 4 to 6 days for 3 consecutive months prior to study entry. Diagnosis of CD or UC must be made by an accredited physician on the basis of typical clinical symptoms and endoscopic, histologic, and/or radiographic findings
- Controls: Women aged 18-48 years with regular menstrual cycles and without a diagnosis of CD will qualify for the study. Controls may be using oral, transdermal or intravaginal hormonal contraception for the purpose of birth control. Regular menstrual cycles will be defined as described above. Frequency matching will be used to ensure controls are aged-matched.
- Exclusion criteria include
- Inability to give written informed consent
- Pregnancy or breast feeding
- Primary or secondary amenorrhea
- Recent (within past 3 months) abdominal or gynecologic surgery
- Current or recent use (within past 3 months) of intradermal
- Injectable or intrauterine (hormonal or non-hormonal) contraception
- Less than 3 months post-partum, or post-menopausal status
- Women within 3 years of menarche will also be excluded due to the high prevalence of anovulatory cycles during this period
- Women will be excluded if they have a diagnosis of irritable bowel syndrome, or other functional bowel disorder
- Women with established endometriosis, pelvic inflammatory disease or other significant gynecologic pathology will also be excluded
- All participants with major medical issues, besides CD, as judged by the research team, will be excluded
- Major medical issues include significant disease of any organ system, such as heart failure, emphysema, or kidney failure
Exclusion
Key Trial Info
Start Date :
May 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT02274714
Start Date
May 1 2010
End Date
January 1 2017
Last Update
January 23 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States, 53792