Hormonal Contraceptives for Inflammatory Bowel Disease

Overseen By Corinne Sexsmith

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Utah

Must be taking: Hormonal contraception

Disqualifiers: Pregnancy, Breastfeeding, Hysterectomy, Menopausal, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

200 Participants Needed

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.

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{5 11 12 13 14}

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

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (phone or in-person)

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.

1 week

1 visit (in-person or virtual)

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.

12 weeks

Weekly virtual surveys, monthly in-person visits for subset

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.

4 weeks

Treatment Details

Interventions

• ENG Implant
• LNG IUD

Trial Overview 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.

Participant Groups

Group I: Naturally cycling participants Experimental Treatment 3 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 users Active Control 3 Interventions

Females with inflammatory bowel disease who use hormonal contraception (combination oral contraceptives, the etonogestrel implant, or the levonorgestrel intrauterine device)

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical performance of the levonorgestrel intrauterine system in routine use by the UK Family Planning and Reproductive Health Research Network: 5-year report. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Complications and continuation rates associated with 2 types of long-acting contraception. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Oral Progestogens Versus Levonorgestrel-Releasing Intrauterine System for Treatment of Endometrial Intraepithelial Neoplasia. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Levonorgestrel-releasing intrauterine system--the discontinuing story. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment of symptomatic adenomyosis with the levonorgestrel-releasing intrauterine system. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Contraception, Venous Thromboembolism, and Inflammatory Bowel Disease: What Clinicians (and Patients) Should Know. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Contraceptive method selection by women with inflammatory bowel diseases: a cross-sectional survey. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Fertility and Contraception in Women With Inflammatory Bowel Disease. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Contraceptive use among women with inflammatory bowel disease: A systematic review. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Use of contraceptives and risk of inflammatory bowel disease: a nested case-control study. [2022]

11. Ireland pubmed.ncbi.nlm.nih.gov

Continuous combined parenteral estrogen substitution and intrauterine progestogen delivery: the ideal HST combination? [2014]

12. China pubmed.ncbi.nlm.nih.gov

[Clinical study of levonorgestrel-releasing intrauterine system for adenomyosis]. [2013]

13. China pubmed.ncbi.nlm.nih.gov

[Effect of levonorgestrel-releasing intrauterine system in the treatment of adenomyosis]. [2013]

14. Australia pubmed.ncbi.nlm.nih.gov

The effect of the levonorgestrel releasing intrauterine system on endometrial hyperplasia: an Australian study and systematic review. [2018]