Crohn's DiseaseNCT02274714
Dysmenorrhea in Women With Crohn's Disease and Ulcerative Colitis
An observational study of Crohn's Disease and Ulcerative Colitis, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- What is being tested?
- Questionnaire Only
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792
About this study
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.
Read the 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.
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Being tested
- Questionnaire Only
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire OnlyOther
Subjects will have an interview with a study coordinator to fill out questionnaires for the study
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Questionnaire Only | |
| Control (without IBD) | Women aged 18-48 years with regular menstrual cycles and without a diagnosis of CD will qualify for the study Receives: Other: Questionnaire Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 year study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startMay 2010
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumona Saha, MD, MS, Principal investigator, University of Wisconsin Hospital & Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274714
- Sponsor's protocol ID
- MDQ
- Status last verified
- Jan 2017
- First submitted
- 15 Oct 2014
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysmenorrhea in Women With Crohn's Disease and Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02274714
- Acronym / sponsor ID
- MDQ
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case (with IBD) | – | Other: Questionnaire OnlyWomen aged 18-48 years with regular menstrual cycles AND with an established diagnosis of CD or UC involving the small bowel, colon or both |
| Control (without IBD) | – | Other: Questionnaire OnlyWomen aged 18-48 years with regular menstrual cycles and without a diagnosis of CD will qualify for the study |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire OnlySubjects will have an interview with a study coordinator to fill out questionnaires for the study | Other | Case (with IBD), Control (without IBD) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumona Saha, MD, MS principal investigator
University of Wisconsin Hospital & Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Ulcerative Colitis, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Dysmenorrhea in menstruating women with and without IBD (time frame: 5 year study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2017.