What side effects are associated with this type of intervention?

Common treatments for Inflammatory Bowel Disease (IBD) include hormonal therapies and glucocorticoids. Hormonal treatments, like oral contraceptives, can cause side effects such as thromboembolism, particularly in patients with thrombophilic disorders or a history of venous thromboembolic events. Drospirenone-containing contraceptives may lead to hyperkalemia and are not recommended for those with renal impairment or adrenal insufficiency. Glucocorticoids, used for rapid symptom relief, can result in long-term side effects like bone density loss, increased infection risk, and adrenal suppression. These treatments require careful medical supervision to ensure safety and efficacy.

What prior FDA approvals exist?

FDA-approved treatments for Inflammatory Bowel Disease (IBD) primarily include aminosalicylates (such as mesalamine), corticosteroids, immunomodulators (such as azathioprine and methotrexate), and biologic agents (such as infliximab and adalimumab). While these treatments focus on reducing inflammation and managing symptoms, hormonal contraception methods like the levonorgestrel intrauterine device and combination oral contraceptives are being studied for their potential to alleviate menstrual-related IBD symptoms. This emerging area of research aims to improve the quality of life for premenopausal women with IBD by addressing hormonal influences on the disease.

What other types of research exist?

Promising novel alternatives to hormonal contraception for IBD patients include non-hormonal intrauterine devices (IUDs) such as the copper IUD, which provides effective contraception without hormonal influence. Additionally, advancements in anti-inflammatory biologics and targeted therapies for IBD, such as TNF inhibitors and integrin receptor antagonists, may help manage IBD symptoms and improve quality of life. These treatments focus on reducing inflammation and controlling IBD symptoms, potentially alleviating menstrual-related IBD symptoms indirectly.

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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

No Placebo-Only Group

Summary

This trial is testing hormonal birth control methods to see if they can help premenopausal women with IBD who have worse symptoms during their periods. By managing hormone levels, these contraceptives might reduce the severity of these symptoms.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Acceptability and adherence to electronic PRO surveys

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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)

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Inflammatory Bowel Disease (IBD) include hormonal therapies, such as estrogen-progestin contraceptives, which can help regulate menstrual cycles and potentially alleviate cyclical IBD symptoms. These hormonal treatments work by stabilizing hormone levels, reducing inflammation, and modulating immune responses. This is particularly important for IBD patients as hormonal fluctuations can exacerbate symptoms like abdominal pain, diarrhea, and fatigue. By managing these hormonal changes, patients may experience improved quality of life and better disease control.

Sex Differences in Treatment Strategies Among Patients With Ulcerative Colitis: A Retrospective Cohort Analysis of Privately Insured Patients.