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NCT05610527 · ClinicalTrials.gov registry record
Hormonal Influences on Inflammatory Bowel Diseases
A clinical trial, sponsored by University of Utah.
- Completed
- Registry status
- 50
- Enrollment target
NCT05610527 is a clinical trial that has completed, run by University of Utah. The registered enrollment target is 50 participants.
The verdict
NCT05610527 has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study Summary
Of the 1.8 million females with inflammatory bowel diseases (IBD) in the US, over half of those who are premenopausal suffer from cyclical menstrual-related IBD symptoms, regardless of how well their disease is controlled. Despite the significant impact that cyclical IBD symptoms, such as abdominal pain, diarrhea, and fatigue have on quality of life, evidence about how to alleviate these symptoms is lacking. In other chronic conditions which are hormonally influenced, such as epilepsy, hormonal contraception may be used to favorably impact disease-related symptoms associated with menses and improve quality of life. In our previous cross-sectional study, 47% of the levonorgestrel intrauterine device users and 19% of combination oral contraceptive users reported improvement in their cyclical IBD symptom. All hormonal methods may plausibly improve symptoms, but prospective, rigorous data evaluating their efficacy for this purpose are lacking. In order to design a future comparative effectiveness trial on the effect of hormonal contraceptive methods on menstrual-related IBD symptoms, we propose this pilot prospective cohort study of 200 females with IBD: 100 naturally cycling and 100 hormonal contraception users. We will gain essential knowledge on IBD-specific influences on contraceptive method selection, willingness to be randomized to methods, the ability of IBD patient reported outcome (PRO) instruments to differentiate between non-menstrual and menstrual-related IBD symptoms, and assess the potential role of inflammatory markers as outcome measures in future trials. We will recruit participants from the University of Utah IBD Center and clinics, other Utah gastroenterology providers, and through social media ads. Total study commitment will be \~12 weeks. Study activities will include daily and weekly text message surveys, as well as blood draws and fecal samples for inflammatory markers in a subset of participants which are commonly used for IBD management. Our ai
Interventions
- OTHER Proposed study design and randomization scenarios
- OTHER Repeated measures of validated Inflammatory Bowel Disease Patient Reported Outcome Instruments
- OTHER Inflammatory marker collection and assessment for correlation with PRO responses and menstrual timing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-07-01 |
| Est. Completion | 2025-12-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05610527
The ClinicalTrials.gov registry entry for NCT05610527 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Proposed study design and randomization scenarios is the first listed.
NCT05610527 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05610527 about?
NCT05610527 is a clinical study titled "Hormonal Influences on Inflammatory Bowel Diseases". Of the 1.8 million females with inflammatory bowel diseases (IBD) in the US, over half of those who are premenopausal suffer from cyclical menstrual-related IBD symptoms, regardless of how well their disease is controlled. Despite the significant impact that cyclical IBD symptoms, such as abdominal ...
What is the current status of trial NCT05610527?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2025-07-01. Estimated completion is 2025-12-09.
What interventions are being tested in trial NCT05610527?
The interventions under investigation include: Proposed study design and randomization scenarios (OTHER), Repeated measures of validated Inflammatory Bowel Disease Patient Reported Outcome Instruments (OTHER), Inflammatory marker collection and assessment for correlation with PRO responses and menstrual timing (OTHER).
Who is sponsoring clinical trial NCT05610527?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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