- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02274714
Dysmenorrhea in Women With Crohn's Disease and Ulcerative Colitis
January 20, 2017 updated by: University of Wisconsin, Madison
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
203
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin Hospital & Clinics
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 48 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
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.
Controls: Women aged 18-48 years with regular menstrual cycles and without a diagnosis of CD will qualify for the study
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Case (with IBD)
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
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Subjects will have an interview with a study coordinator to fill out questionnaires for the study
|
Control (without IBD)
Women aged 18-48 years with regular menstrual cycles and without a diagnosis of CD will qualify for the study
|
Subjects will have an interview with a study coordinator to fill out questionnaires for the study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of Dysmenorrhea in menstruating women with and without IBD
Time Frame: 5 year study
|
we propose to characterize and compare the prevalence of dysmenorrhea in menstruating women with and without CD and UC.
|
5 year study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sumona Saha, MD, MS, University of Wisconsin Hospital & Clinics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
October 15, 2014
First Submitted That Met QC Criteria
October 21, 2014
First Posted (Estimate)
October 24, 2014
Study Record Updates
Last Update Posted (Estimate)
January 23, 2017
Last Update Submitted That Met QC Criteria
January 20, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDQ
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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