Hormonal Influences on Inflammatory Bowel Diseases

NCT05610527 | Completed

• 1 other identifier: IRB_00160085
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 aims include: (1) To identify preferences and reasons for contraceptive method selection (or non-use) and willingness to participate in a randomized controlled trial, to inform feasibility of a future trial, (2) To obtain estimates of means and standard deviations for the validated Crohn's Disease and Ulcerative Colitis PRO Instruments by menstrual timing in naturally-cycling participants and between bleeding and non-bleeding days in hormonal contraception users, and (3) To assess correlation between inflammatory marker changes (fecal calprotectin \& high sensitivity C-reactive protein), menstrual timing or bleeding/non-bleeding days, and IBD PRO responses, in a subset of 30% of Aim 1 participants. This pilot will inform a future trial design to define non-contraceptive benefits of hormonal contraception on cyclical IBD symptoms. This line of inquiry will allow for an adjuvant approach for IBD symptom management that is sex-specific and addresses both concerns for hormonal triggers and the need for highly-effective contraception for those who desire it.

Conditions

Inflammatory Bowel Diseases; Contraception; Menstrual Problem

Keywords

randomization; inflammatory markers; patient reported outcome measures

Outcome Measures

Primary Outcomes (3)

• Willingness to be randomized and reason and preferences for contraceptive method selection in the setting of IBD

  Proportion of participants willing to be randomized in each hypothetical study scenario based on the adapted 7-item Attitudes to Randomized Trials Questionnaire and Proportion of participants who select each hormonal methods vs non-hormonal and characteristics as desirable

  Collected on enrollment survey

• Change in IBD PRO responses/scores and by menstrual timing in natural cycling and bleeding vs non-bleeding days in hormonal contraception users

  UC PRO or CD PRO instrument scores by module. Modules 1-3 assess daily symptoms and modules 4-5 assess weekly quality of life measures.

  Daily symptom modules and weekly quality of life modules for 12 weeks

• Correlation in inflammatory marker changes to IBD PRO responses

  hsCRP and fecal calprotectin levels measured at baseline and at each collection visit throughout study UC PRO or CD PRO instrument scores by module. Measured daily or weekly on follow-up surveys.

  Weekly blood draws (13 total) and monthly stool sample collection (4 samples)

Secondary Outcomes (1)

• Acceptability and adherence to electronic PRO surveys

  12 weeks

Study Arms (2)

Hormonal contraception users

Females with inflammatory bowel disease who use hormonal contraception (combination oral contraceptives, the etonogestrel implant, or the levonorgestrel intrauterine device)

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

Naturally cycling participants

Females with inflammatory bowel disease who do not use hormonal contraception and have regular menstrual cycles (self or partner permanent contraception, copper IUD, abstinence, barrier methods, and fertility awareness methods)

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

Interventions

Proposed study design and randomization scenarios OTHER

Present hypothetical study scenarios and assess willingness to be randomized based on the adapted 7-item Attitudes to Randomized Trials Questionnaire

Hormonal contraception users; Naturally cycling participants

Repeated measures of validated Inflammatory Bowel Disease Patient Reported Outcome Instruments OTHER

We will electronically administer Ulcerative Colitis (UC) and Crohn's Disease validated PRO instruments, including the daily symptom modules and weekly quality of life modules for 12 weeks to all 200 participants

Also known as: UC PRO Instrument, Crohn's PRO Instrument

Hormonal contraception users; Naturally cycling participants

Inflammatory marker collection and assessment for correlation with PRO responses and menstrual timing OTHER

In an Aim 3 sub study of 30% of participants, we will collect inflammatory markers commonly used to assess disease activity and risk of relapse in inflammatory bowel disease patients, including weekly blood samples of high sensitivity c-reactive protein (13 total) and monthly ferritin, albumin, and WBC, as well monthly stool specimens (4 total) for fecal calprotectin

Also known as: Inflammatory markers

Hormonal contraception users; Naturally cycling participants

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Must have menstrual cycles
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Between 18-45 years Fluent in English and/or Spanish Have biopsy-proven UC or CD (confirmed by medical records and/or through screening questions- see below enrollment procedures Aim 1) Willing to comply with study activities Have a reliable method to receive emails for e-diary reminders and completion Regular menses (21-35d) when not on hormonal contraception For the hormonal contraception cohort, use of the LNG IUD, ENG implant, or COC For the naturally-cycling cohort, use of any non-hormonal method of contraception, including: self or partner permanent contraception, copper IUD, abstinence, barrier methods, and fertility awareness methods

You may qualify if:

• Between 18-45 years old
• Fluent in English and/or Spanish
• Have biopsy-proven UC or CD (confirmed by medical records and/or through screening questions- see below enrollment procedures Aim 1)
• Willing to comply with study activities
• Have a reliable smartphone or text-message capable device for e-diary reminders and completion
• Regular menses (21-35d) when not on hormonal contraception
• For the hormonal contraception cohort, use of the LNG IUD, ENG implant, or COC
• For the naturally-cycling cohort, use of any non-hormonal method of contraception, including: self or partner permanent contraception, copper IUD, abstinence, barrier methods, and fertility awareness methods

You may not qualify if:

• Current pregnancy
• Breastfeeding without resumption of 2 normal menses
• Desires starting, stopping or switching hormonal contraception during the 12-week study timeframe
• History of hysterectomy
• Menopausal (no menses for 12+months when not on hormonal contraception
• Use of systemic gender-affirming hormone therapy (e.g. testosterone)
• Indeterminant or microscopic colitis
• Participation in any other clinical trials during this study timeline

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Menstruation Disturbances

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Lori Gawron

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: November 9, 2022
• Study Start: July 1, 2025
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)