Reviewed by Michael Gill, B. Sc.
Image of University of Utah in Salt Lake City, United States.
Phase-Based Progress Estimates
1
Effectiveness
1
Safety

52mg Levonorgestrel Intrauterine Devicefor menstrual problems

18 - 65
Female
Of the 1.8 million U.S. women with inflammatory bowel diseases (IBD), over half of those who are premenopausal suffer from cyclical menstrual-related IBD symptoms, regardless of how well their disease is controlled. Despite the significant impact that cyclical IBD symptoms have on quality of life, evidence about how to alleviate these symptoms is lacking. In other chronic conditions which are hormonally influenced, such as epilepsy, hormonal contraception may be used to favorably impact disease-related symptoms associated with menses and improve quality of life. Long acting reversible contraception, including the etonogestrel (ENG) contraceptive implant and levonorgestrel (LNG) intrauterine device (IUD), are the most effective contraceptive options with excellent safety profiles and are highly desired if access barriers are removed, thus ideal for study in this population. In our previous cross-sectional study, 47% of the levonorgestrel (LNG) IUD users reported improvement in their cyclical IBD symptoms, but ENG implant use was uncommon and prospective data on the effect of either the IUD or implant on symptoms remain lacking. In order to design a future comparative effectiveness trial on the effect of the ENG implant and LNG IUD on menstrual-related IBD symptoms, the investigators propose this pilot randomized controlled trial with a participant-preference arm to define a feasible study design and recruitment plan, determine metrics to differentiate between non-menstrual and menstrual-related IBD symptoms, and explore the potential role of use of inflammatory markers in future trials. The investigators will recruit participants from the University of Utah IBD Center and clinics and through social media ads. Total study commitment will be ~8 months which includes two spontaneous menstrual cycles prior to contraceptive initiation and then six months of follow-up. Study activities will include daily and weekly text message surveys, as well as blood draws and fecal samples for inflammatory markers commonly used for IBD management. Our aims include: (1) To determine acceptability of randomization to the ENG contraceptive implant or 52mg-LNG IUD and in those who decline, acceptability of participation in a participant-preference arm, (2) To obtain estimates of means and standard deviations in established IBD symptom scales (Harvey Bradshaw and partial Mayo) and IBD quality of life measures across the phases of two menstrual cycles and then for 6 months after contraceptive method initiation, and (3) To obtain preliminary estimates of inflammatory marker variation across menstrual phases and pre- and post- contraceptive initiation. This pilot will inform a future trial design and this line of inquiry will allow for an adjuvant approach for IBD symptom management that is sex-specific and addresses both concerns for hormonal triggers and the need for highly-effective contraception for those who desire it.
Waitlist Available
Has No Placebo
University of UtahLori Gawron
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About The Author

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: October 31st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

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