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Completed

NCT Number: NCT02274714

Dysmenorrhea in Women With Crohn's Disease and Ulcerative Colitis

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.

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Key information

Age range

18 year–48 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Only

Other

Subjects will have an interview with a study coordinator to fill out questionnaires for the study

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Oct 24, 2014
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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