Clinical trial NCT02274714: Dysmenorrhea in Women With Crohn's Disease and Ulcerative Colitis
Official title: Dysmenorrhea in Women With Crohn's Disease and Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Ulcerative Colitis
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2014-10-24
Enrollment: 203
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Prevalence of Dysmenorrhea in menstruating women with and without IBD
timeFrame: 5 year study
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin Hospital & Clinics
name: Sumona Saha, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: