Dysmenorrhea in Women With Crohn's Disease and Ulcerative Colitis

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

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 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.

Official Title
-----------------
Dysmenorrhea in Women With Crohn's Disease and Ulcerative Colitis

Conditions
-----------------
Crohn's Disease, Ulcerative Colitis

Intervention / Treatment
-----------------
* Other: Questionnaire Only


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case (with IBD)<br>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 | Other: Questionnaire Only<br>* Subjects will have an interview with a study coordinator to fill out questionnaires for the study<br>|
| Control (without IBD)<br>Women aged 18-48 years with regular menstrual cycles and without a diagnosis of CD will qualify for the study | Other: Questionnaire Only<br>* Subjects will have an interview with a study coordinator to fill out questionnaires for the study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Dysmenorrhea in menstruating women with and without IBD | we propose to characterize and compare the prevalence of dysmenorrhea in menstruating women with and without CD and UC. | 5 year study |