Hormonal Contraceptives for Inflammatory Bowel Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
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 it safe to use hormonal contraceptives for inflammatory bowel disease?
Hormonal contraceptives, like the ENG Implant and LNG IUD, are generally safe, but there are concerns about an increased risk of blood clots (thrombosis) in women with inflammatory bowel disease (IBD). It's important to discuss with a doctor, especially if you have active IBD or a history of blood clots.12345
How does the drug differ from other treatments for inflammatory bowel disease?
The treatment involves hormonal contraceptives, specifically the levonorgestrel-releasing intrauterine system (LNG-IUS), which is unique because it is primarily used for contraception and conditions like adenomyosis, rather than inflammatory bowel disease. This approach is novel as it explores the potential benefits of hormonal regulation in managing inflammation, which is different from standard treatments that typically focus on immune suppression or anti-inflammatory drugs.678910
What data supports the effectiveness of the treatment ENG Implant, LNG IUD for Inflammatory Bowel Disease?
The levonorgestrel-releasing intrauterine system (LNG IUD) is effective for contraception and treating heavy menstrual bleeding, but it has high discontinuation rates due to side effects. The ENG implant is also used for long-acting contraception. While these treatments are effective for their approved uses, there is no direct evidence supporting their effectiveness for Inflammatory Bowel Disease.611121314
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