Trial Summary
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.
Research Team
Lori Gawron, MD
Principal Investigator
University of Utah
Eligibility Criteria
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
Intend to use a LNG IUD or ENG implant and willing to consider randomization
Have a regular menstrual cycle (21-35 days)
Fluent in English and/or Spanish
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Exclusion Criteria
Breastfeeding without resumption of 2 normal menses
History of intolerance/ side effects with ENG Implant/LNG IUD
Contraindication to ENG implant or LNG IUD (U.S. Medical Eligibility Criteria for Contraceptive Use category 3 or 4)
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Treatment Details
Interventions
- ENG Implant (Hormone Therapy)
- LNG IUD (Hormone Therapy)
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor
Trials
1,169
Recruited
1,623,000+
Jeffrey Wilkins
University of Utah
Chief Medical Officer since 2022
MD from Meharry Medical College
Stephen Tullman
University of Utah
Chief Executive Officer since 2022
BS in Accounting from Rutgers University