Hormonal Contraceptives for Inflammatory Bowel Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how hormonal contraceptives might assist women with inflammatory bowel disease (IBD) who experience menstrual-related symptoms such as abdominal pain, diarrhea, and fatigue. Researchers aim to determine if hormonal contraception, like the levonorgestrel IUD (LNG IUD) or etonogestrel implant (ENG Implant), can alleviate these symptoms. Women with IBD and regular menstrual cycles, regardless of their use of hormonal contraception, may qualify for this study. Participants will provide essential data through surveys and samples, aiding future research on managing IBD symptoms. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance symptom management for many women with IBD.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are using hormonal contraception, you should not start, stop, or switch methods during the 12-week study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that hormonal birth control methods like the etonogestrel implant (ENG) and the levonorgestrel intrauterine device (LNG IUD) are generally safe for people with inflammatory bowel disease (IBD). Studies have found these methods to be highly effective at preventing pregnancy and safe for those with IBD. Only 5% of users reported worsening symptoms, indicating these methods are usually well-tolerated.
For the ENG implant, research supports its use without restrictions for people with IBD. However, some studies noted a slightly higher risk of infections in individuals with weakened immune systems, though these cases are rare.
The LNG IUD also carries a low risk of complications. Issues like pelvic inflammatory disease, an infection of the female reproductive organs, occur in less than 1% of users, regardless of age. This suggests that both the ENG implant and LNG IUD are safe options for managing IBD symptoms related to menstrual cycles.12345Why are researchers excited about this trial?
Researchers are excited about using hormonal contraceptives like the ENG implant and LNG IUD for inflammatory bowel disease (IBD) because these treatments could offer a dual benefit. Unlike standard IBD treatments that focus on reducing inflammation through medications like corticosteroids or biologics, these hormonal methods may help manage symptoms by stabilizing hormonal fluctuations that could affect disease activity. The ENG implant and LNG IUD are already well-known for their effectiveness and convenience as contraceptives, providing long-term and reliable options without daily dosing, which could also improve quality of life for people with IBD.
What evidence suggests that hormonal contraceptives might be an effective treatment for IBD symptoms?
Research has shown that hormonal birth control might alleviate period-related symptoms in women with inflammatory bowel disease (IBD). In one study, 47% of women using the levonorgestrel intrauterine device (LNG IUD) reported improvement in their IBD symptoms during their menstrual cycle. Similarly, 19% of women using estrogen-based birth control felt better. Only about 5% of women using hormonal methods experienced worsening symptoms. This trial will compare naturally cycling participants with those using hormonal contraception, including options like the LNG IUD and etonogestrel (ENG) implants, to assess their impact on period-related IBD symptoms. While more research is needed, these early findings offer promise for those seeking relief from these symptoms.12678
Who Is on the Research Team?
Lori Gawron, MD
Principal Investigator
University of Utah
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Enrollment and Baseline Assessment
Participants complete a phone screening, discuss study procedures, and complete an enrollment survey assessing sociodemographic and reproductive characteristics, IBD history, and menstrual cycle timing and symptoms.
Study Engagement
Participants engage in study activities including daily and weekly text message surveys, and a subset participate in blood draws and fecal sample collection for inflammatory markers.
Follow-up
Participants are monitored for changes in IBD PRO responses and inflammatory markers, and their willingness to be randomized in future trials is assessed.
What Are the Treatments Tested in This Trial?
Interventions
- ENG Implant
- LNG IUD
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor