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Hormonal Contraceptives for Inflammatory Bowel Disease

N/A
Waitlist Available
Led By Lori Gawron
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly blood draws (13 total) and monthly stool sample collection (4 samples)
Awards & highlights

Study Summary

This trial aims to explore if hormone-based contraception (IUD, implant) can improve cyclical IBD symptoms in premenopausal women. It'll involve surveys, blood & fecal samples to measure inflammatory markers & quality of life. If successful, it could offer an adjuvant approach to better manage IBD.

Who is the study for?
This trial is for premenopausal women with inflammatory bowel disease (IBD) who experience cyclical IBD symptoms related to their menstrual cycle. Participants should be between 18-45 years old, have a regular menstrual cycle, and not be at risk of pregnancy or willing to use condoms. They must intend to use an ENG implant or LNG IUD for birth control and agree possibly being randomly assigned one.Check my eligibility
What is being tested?
The study tests if the ENG contraceptive implant or LNG intrauterine device (IUD) can alleviate cyclical IBD symptoms associated with menstruation. It's a pilot randomized controlled trial that includes daily/weekly surveys, blood draws, and fecal samples over approximately 8 months.See study design
What are the potential side effects?
Potential side effects from the ENG implant or LNG IUD may include changes in bleeding patterns, abdominal/pelvic pain, headache, acne, breast tenderness, mood swings and possible discomfort at the site of insertion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly blood draws (13 total) and monthly stool sample collection (4 samples)
This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly blood draws (13 total) and monthly stool sample collection (4 samples) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in IBD PRO responses/scores and by menstrual timing in natural cycling and bleeding vs non-bleeding days in hormonal contraception users
Correlation in inflammatory marker changes to IBD PRO responses
Willingness to be randomized and reason and preferences for contraceptive method selection in the setting of IBD
Secondary outcome measures
Acceptability and adherence to electronic PRO surveys

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Naturally cycling participantsExperimental Treatment3 Interventions
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)
Group II: Hormonal contraception usersActive Control3 Interventions
Females with inflammatory bowel disease who use hormonal contraception (combination oral contraceptives, the etonogestrel implant, or the levonorgestrel intrauterine device)

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,104 Previous Clinical Trials
1,782,333 Total Patients Enrolled
Lori GawronPrincipal InvestigatorUniversity of Utah

Media Library

Naturally cycling participants Clinical Trial Eligibility Overview. Trial Name: NCT05610527 — N/A
Inflammatory Bowel Disease Research Study Groups: Naturally cycling participants, Hormonal contraception users
Inflammatory Bowel Disease Clinical Trial 2023: Naturally cycling participants Highlights & Side Effects. Trial Name: NCT05610527 — N/A
Naturally cycling participants 2023 Treatment Timeline for Medical Study. Trial Name: NCT05610527 — N/A
~133 spots leftby Aug 2026
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