Free or Discounted IUD Vouchers to Prevent Unintended Pregnancies

(M-CARES-K Trial)

Recruiting at 8 trial locations

Overseen By Vanessa Lang, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Pregnant, Not seeking contraceptives, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

4700 Participants Needed

Trial Summary

What is the purpose of this trial?

This project builds on the Michigan Contraceptive Access Research and Evaluation Study (M-CARES) to evaluate the long-term effects of mothers' access to free contraceptives and reductions in unintended pregnancies on their children's well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment in preventing unintended pregnancies?

Research shows that the levonorgestrel intrauterine system (LNG IUS), which includes brands like Mirena and Kyleena, is one of the most effective forms of contraception. It also offers important health benefits beyond preventing pregnancies, such as controlling menstrual-related issues. ^{1 2 3 4 5}

Is the levonorgestrel IUD safe for use in humans?

The levonorgestrel intrauterine system (IUD), including brands like Mirena, Kyleena, and Skyla, has been used safely for contraception and treating heavy menstrual bleeding. It has been approved by health authorities like the FDA and has been available in the U.S. since 2000 and in Europe since 1990, indicating a long history of safe use. ^{1 2 3 6 7}

How does the IUD treatment differ from other treatments for preventing unintended pregnancies?

The IUD treatment is unique because it is a long-term, reversible contraceptive method that requires only a one-time insertion and can remain effective for 5-10 years, reducing the need for daily or frequent compliance. It is also cost-effective and has a favorable safety profile compared to older IUDs, making it a reliable option for preventing unintended pregnancies. ^{1 4 8 9 10}

Eligibility Criteria

This trial is for mothers aged 18-35 who are not pregnant, do not wish to become pregnant within a year, and are seeking care at Planned Parenthood of Michigan. They must be biologically female, able to have children, and face costs for contraceptives.

Inclusion Criteria

I am a woman aged 18-35, not pregnant, don't plan to be for a year, need contraception, and face costs at Planned Parenthood.

I am a child aged 0-17, and my mother is part of the M-CARES study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Mothers receive a voucher providing access to no-cost contraception for 100 days

14 weeks

Follow-up

Participants are monitored for children's well-being and development through surveys and administrative data

5 years

Treatment Details

Interventions

• Mother receives voucher valued at 100% of cost of name-brand IUD
• Mother receives voucher valued at 50% of cost of name-brand IUD

Trial Overview The study provides vouchers covering either 100% (from March 4, 2019) or 50% (until March 3, 2019) of the cost for name-brand IUDs to see how free or reduced-cost birth control affects their children's well-being over time.

Participant Groups

Group I: Experimental Group Experimental Treatment 2 Interventions

Mothers randomized to receive a voucher to be used at Planned Parenthood to cover the cost of contraceptives

Group II: Control Group Active Control 1 Intervention

Mothers randomized to NOT receive a voucher. Mothers in this arm receive the Planned Parenthood standard of care priced according to the Planned Parenthood sliding scale.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Planned Parenthood Federation of America

Collaborator

Trials

17

Recruited

21,600+

National Opinion Research Center

Collaborator

Trials

15

Recruited

251,000+

Findings from Research

The levonorgestrel intrauterine system (LNG-IUS), known as Mirena, is an FDA-approved device that effectively prevents unintended pregnancies and treats abnormal uterine bleeding, offering significant benefits for women's health.

Despite its proven efficacy and cost-effectiveness, the LNG-IUS remains underutilized in the United States, highlighting a gap in the adoption of evidence-based practices in women's healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost effectiveness in obstetrics and gynecology: The levonorgestrel intrauterine system. Mattson, L.[2013]

The levonorgestrel intrauterine system (IUS) known as Kyleena was approved for use in the UK in 2016 and is effective for contraception for up to 5 years, containing 19.5mg of levonorgestrel.

Kyleena is the fourth LNG IUS product licensed in the UK and is reported to have advantages over other similar devices like Mirena and Jaydess, although specific benefits were not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kyleena - another levonorgestrel IUS. [2018]

The new, affordable levonorgestrel intrauterine system (LNG IUS) from Medicines360 is expected to have a direct service delivery cost per couple-years of protection that is competitive with other contraceptive methods in Kenya, potentially increasing its uptake.

Key opinion leaders believe that the LNG IUS's non-contraceptive health benefits, such as reduced menstrual bleeding, will attract women, but addressing myths and misconceptions about IUDs and prioritizing demand creation and provider training will be crucial for successful implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding Access to a New, More Affordable Levonorgestrel Intrauterine System in Kenya: Service Delivery Costs Compared With Other Contraceptive Methods and Perspectives of Key Opinion Leaders. Rademacher, KH., Solomon, M., Brett, T., et al.[2018]

The etonogestrel implant and levonorgestrel IUD resulted in the lowest number of pregnancies and costs over a 3-year period, costing $1.75 million and $2.0 million respectively, compared to $3.4 million for generic oral contraceptives.

Despite higher initial costs, the etonogestrel implant and levonorgestrel IUD proved to be more cost-effective within one year due to lower failure rates and reduced pregnancy-related expenses, making them the least expensive hormonal contraceptives overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Budget impact analysis of 8 hormonal contraceptive options. Crespi, S., Kerrigan, M., Sood, V.[2019]

Ulipristal acetate is more effective and cost-efficient than levonorgestrel when taken within 24 hours after unprotected intercourse, potentially saving significant costs associated with unintended pregnancies.

Overall, ulipristal acetate is a cost-effective option compared to levonorgestrel within 72 hours, suggesting that providing it free of charge to minors could be beneficial for reducing unintended pregnancy rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cost-Effectiveness of Emergency Hormonal Contraception with Ulipristal Acetate versus Levonorgestrel for Minors in France. Schmid, R.[2023]

Jaydess/Skyla and Kyleena are low-dose levonorgestrel releasing intrauterine systems (LNG-IUS) that differ from Mirena in their pharmacological properties and physical dimensions, but there are currently no clear guidelines on when to use them over Mirena.

The clinical research available on Jaydess/Skyla and Kyleena is limited and primarily sponsored by the manufacturers, leading to inconsistencies in terminology and insufficient information for clinicians to make informed decisions about their use compared to other LNG-IUS options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clarification of the role of the Jaydess(Skyla) LNG- IUS 13.5mg and Kyleena LNG-IUS 19.5mg as intrauterine contraceptive systems. Goldstuck, ND.[2018]

The levonorgestrel intra-uterine system (IUS) is effective not only as a contraceptive but also as a treatment for idiopathic menorrhagia, which is heavy menstrual bleeding without a known cause.

The IUS is particularly beneficial for women who need both contraception and management of heavy menstrual bleeding, highlighting its dual purpose and safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Levonorgestrel intra-uterine system for menorrhagia. [2019]

Intrauterine devices (IUDs) are highly effective contraceptives that require only a one-time insertion and can last for 5-10 years, making them a reliable option for preventing unintended pregnancies.

The newer IUDs, such as ParaGard and Mirena, have superior safety profiles compared to older models and demonstrate improved efficacy in preventing both intrauterine and ectopic pregnancies, highlighting their potential as a preferred contraceptive method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in contraception: IUDs from a managed care perspective. Doyle, J., Stern, L., Hagan, M., et al.[2008]

The increased use of intrauterine devices (IUDs) in the US has likely contributed to a significant decline in unintended pregnancies, highlighting their effectiveness as a contraceptive method.

All available IUDs, including hormonal and copper options, are shown to be safe and effective, with newer models tested in diverse populations, although larger studies have raised awareness about potential risks, such as perforation, particularly in postpartum and breastfeeding women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in intrauterine device use: focus on the US. Nelson, AL., Massoudi, N.[2023]

The intrauterine device (IUD) is one of the most effective and safe contraceptive methods available, yet its usage in the United States is less than 1% due to historical concerns and misconceptions.

Misunderstandings about the IUD's safety, mechanism of action, and complication rates have led to inadequate training for physicians, limiting its availability to women who could benefit from this highly effective form of birth control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The intrauterine device: still misunderstood after all these years. Cheng, D.[2014]

References

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

Cost effectiveness in obstetrics and gynecology: The levonorgestrel intrauterine system. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Kyleena - another levonorgestrel IUS. [2018]

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

Expanding Access to a New, More Affordable Levonorgestrel Intrauterine System in Kenya: Service Delivery Costs Compared With Other Contraceptive Methods and Perspectives of Key Opinion Leaders. [2018]

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

Budget impact analysis of 8 hormonal contraceptive options. [2019]

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

The Cost-Effectiveness of Emergency Hormonal Contraception with Ulipristal Acetate versus Levonorgestrel for Minors in France. [2023]

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

Clarification of the role of the Jaydess(Skyla) LNG- IUS 13.5mg and Kyleena LNG-IUS 19.5mg as intrauterine contraceptive systems. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Levonorgestrel intra-uterine system for menorrhagia. [2019]

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

Advances in contraception: IUDs from a managed care perspective. [2008]

9. New Zealand pubmed.ncbi.nlm.nih.gov

New developments in intrauterine device use: focus on the US. [2023]

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

The intrauterine device: still misunderstood after all these years. [2014]