Levonorgestrel IUD for Birth Control
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the Levonorgestrel 52 mg IUD for effectiveness in emergency contraception and same-day start in real-life settings. It targets individuals needing this IUD either after unprotected sex within the last 5 days or to start it more than a week after their last period, without recent unprotected sex. Participants must be fluent in English or Spanish and have a cell phone for study communication. The trial aims to determine if the IUD prevents pregnancy one month after placement. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop using any contraceptive pills, patches, vaginal rings, contraceptive implants, or IUDs for at least 4 weeks before participating. You also cannot have used oral emergency contraception in the last 5 days or injectable hormonal contraceptives in the last 6 months.
What is the safety track record for the Levonorgestrel 52 mg Intrauterine Device?
Research has shown that the levonorgestrel 52 mg intrauterine device (IUD) is both effective and safe, with successful use for up to 8 years. Many studies confirm it is well-tolerated and has a strong safety record.
In past studies, thousands of women used the levonorgestrel IUD, and it received approval for long-term use, indicating thorough safety testing. Some side effects, such as spotting or cramping, can occur, but serious issues are rare. The FDA has already approved this IUD for regular birth control, further supporting its safety.
Overall, for those considering joining this trial, the levonorgestrel IUD is a well-researched and trusted option.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about using the Levonorgestrel 52 mg IUD for emergency contraception because it offers a novel, long-term solution compared to traditional emergency contraceptive pills, like Plan B, which only provide short-term coverage. Unlike standard options that require repeated dosing or do not provide ongoing contraception after the emergency use, this IUD starts working immediately and continues to prevent pregnancy for up to several years. This dual capability—immediate emergency contraception and long-term prevention—sets it apart and could significantly enhance convenience and effectiveness for users.
What is the effectiveness track record for the Levonorgestrel 52 mg IUD for emergency contraception and same-day start use?
Research has shown that the Levonorgestrel (LNG) 52 mg Intrauterine Device (IUD) is highly effective for birth control. Studies indicate it prevents pregnancy more than 99.8% of the time in the first year and over 99.3% of the time over five years. A review of multiple studies found the pregnancy rate with the LNG IUD to be just 0.3%, making it more effective than some other IUDs. Users have reported satisfaction with it, even beyond the usual five-year period. In this trial, participants will receive the LNG IUD as a same-day start or for emergency contraception, exploring its effectiveness in these contexts.36789
Who Is on the Research Team?
David Turok, MD, MPH
Principal Investigator
University of Utah
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Levonorgestrel 52 mg IUD for emergency contraception or same-day start
Follow-up
Participants are monitored for safety and effectiveness after IUD placement
What Are the Treatments Tested in This Trial?
Interventions
- Levonorgestrel 52 MG Intrauterine System
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Week 1: Text daily for seven days. Report occurrences of the following in the last day: presence or absence of bleeding, spotting, pain, sexual intercourse, use of other methods of contraception, IUD expulsion or removal, and report any additional medical care received. Weeks 2 \& 3: Weekly text survey assessing on which days of the previous week participants experienced bleeding and spotting, sexual intercourse, use of other methods of contraception, IUD expulsion or removal, or experienced adverse events. Week 4 Survey: At 28 days, participants will be asked about pregnancy symptoms, concern about pregnancy, and the result of their urine pregnancy test including a prompt to upload a photo of the test.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor
Planned Parenthood Federation of America
Collaborator
Citations
findings from the Mirena Extension Trial
At the end of year 8, most (98.7%, 220/223) of the participants who completed the study remained satisfied with the continued use of the 52-mg ...
findings from the Mirena Extension Trial
During extended use beyond 5 years and up to 8 years, participants reported a decrease in the mean number of bleeding or spotting days with approximately half ...
Mirena® IUD Efficacy | Official HCP Site
Reliable pregnancy protection for up to 8 years. 1 Over 99.8% contraceptive efficacy at year 1 and over 99.3% cumulative efficacy over 5 years.
a meta-analysis of randomized controlled trials
The pregnancy rate is 1.2% for Cu-IUDs >250 mm2 and 0.3% for LNG (52 mg) IUD. Further meta-analysis of six studies revealed that the risk of ...
Contraception with levonorgestrel-releasing intrauterine ...
Recent RCTs indicated that the LNG (52 mg) IUD was more effective than the Cu (380 mm2 and 220 mm2) IUDs in preventing unintended pregnancies., However ...
Levonorgestrel 52 mg intrauterine system efficacy and ...
The levonorgestrel 52 mg intrauterine system is highly effective over 8 years of use and has an excellent extended safety profile.
Mirena® IUD Safety Information | Official HCP Site
Review the safety and full prescribing information for Mirena® (levonorgestrel-releasing intrauterine system) 52 mg IUD.
Mirena® (levonorgestrel-releasing intrauterine system)
In study sites having verifiable data and informed consent, 1169 women 18 to. 35 years of age at enrollment used Mirena for up to 5 years, for a total of 45,000 ...
9.
mayoclinic.org
mayoclinic.org/drugs-supplements/levonorgestrel-intrauterine-route/description/drg-20073437Levonorgestrel (intrauterine route) - Side effects & uses
It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization (pregnancy) is prevented.
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