Dysmenorrhea in Women With Crohn's Disease and Ulcerative Colitis



Status:Completed
Conditions:Colitis, Colitis, Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 48
Updated:4/2/2016
Start Date:May 2010
End Date:December 2015
Contact:Jenny Vue
Email:jxvue@medicine.wisc.edu
Phone:608-263-4185

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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 characterized using previously validated clinical disease activity
indices. General and health-related quality of life will be assessed using validated
measures.

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 hypothesize that CD and UC activity as measured by non-invasive
disease activity scores will be higher, and quality of life lower in women with both CD and
UC and dysmenorrhea. As deciphering this complex relationship may avoid unnecessary testing
or changes in therapy, we propose to characterize and compare the prevalence of dysmenorrhea
in menstruating women with and without CD and UC. Furthermore, we will compare CD and UC
activity and IBD-related quality of life in women with and without dysmenorrhea in a
population of menstruating women with IBD. Lastly, we will compare general quality of life
in women with and without either form of IBD and dysmenorrhea.

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
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Madison, Wisconsin 53792
(608) 263-6400
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