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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ weekly blood draws (13 total) and monthly stool sample collection (4 samples)

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)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,098 Previous Clinical Trials

1,778,430 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: Hormonal contraception users, Naturally cycling participants

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it currently feasible for individuals to join this experiment?

"According to the clinicaltrials.gov page, this medical trial is not actively looking for participants at this time. The study was first posted on March 1st 2023 and last updated on November 3rd 2022; however, there are 264 other trials worldwide accepting patients presently."

Answered by AI

Does this research project permit the participation of elderly individuals?

"Adhering to the prerequisites for enrolling in this clinical trial, prospective participants must be aged between 18 and 45 years old."

Answered by AI

Do I meet the qualifications to participate in this investigation?

"This investigation is looking for 40 individuals between the ages of 18 and 45 that have been clinically diagnosed with an inflammatory bowel disease. Key criteria include: biopsy-verified IBD, a menstrual cycle ranging from 21 to 35 days, English or Spanish fluency, recurrent cyclical symptoms in more than 50% of cycles within the last 6 months (e.g., alterations in bowels habits, abdominal pain), willingness to receive either a LNG intrauterine device or ENG implant as well as randomization, no risk of pregnancy through sterilization techniques/same-sex relationship/abstinence OR using condoms until 7 days after insertion of"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hormonal Influences on Inflammatory Bowel Diseases

2024. "Hormonal Influences on Inflammatory Bowel Diseases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05610527.

All > Inflammatory Bowel Disease