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New treatment option for Contraception
Official title Levonorgestrel 52 mg IUD for Emergency Contraception and Same-Day Start
ClinicalTrials.gov ID: NCT05444582
What this study is testing
What is Levonorgestrel 52 MG Intrauterine System?
Levonorgestrel 52 MG Intrauterine System is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for contraception.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective clinical research study to test the effectiveness of the Levonorgestrel (LNG) 52 mg Intrauterine Device (IUD) for emergency contraception (EC) and same-day start use that will enroll people receiving care at Planned Parenthood affiliates across the U.S. Our prior work demonstrated efficacy (shows that it works in an ideal setting) for the LNG 52 mg IUD for these uses and this study will test effectiveness (how well it works in the real world) in a larger, heterogenous population in a usual care setting where participants select their method and are not randomly assigned to it.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 35, women only
You may be able to join if
- Meet clinic eligibility for IUD placement
- Have a LNG 52 mg IUD placed for either emergency contraception (had unprotected intercourse in the last 5 days) OR Same-day start, \>7 days since the...
- Negative high sensitivity urine pregnancy test prior to IUD placement.
- No known contraindications to the LNG 52 mg IUD per the CDC Medical Eligibility Criteria for Contraceptive Use 2016
- Have had penile-vaginal intercourse at least once since their last menstrual period. If last menstrual period is unknown or irregular, then have had...
You likely can't join if
- Current pregnancy
- Currently Breastfeeding
- Current use of permanent contraception (has had a hysterectomy, tubal permanent contraception, or partner with a vasectomy in the last month)
- Use of any contraceptive pills, patches, vaginal rings or any contraceptive implant or IUD use in the last 4 weeks
- Use of oral emergency contraception in last 5 days
- Vaginal bleeding of unknown etiology
See the full eligibility criteria
- Meet clinic eligibility for IUD placement
- Have a LNG 52 mg IUD placed for either emergency contraception (had unprotected intercourse in the last 5 days) OR Same-day start, \>7 days since the onset of last menstrual period and have no report of unprotected...
- Negative high sensitivity urine pregnancy test prior to IUD placement.
- No known contraindications to the LNG 52 mg IUD per the CDC Medical Eligibility Criteria for Contraceptive Use 2016
- Have had penile-vaginal intercourse at least once since their last menstrual period. If last menstrual period is unknown or irregular, then have had penile-vaginal intercourse at least once in the last month.
- Fluent in English or Spanish
- Working Cell Phone number that receives text messages
- Willing to comply with the study requirements including providing 1-month follow up data including a urine pregnancy test result one month after IUD placement
- Current pregnancy
- Currently Breastfeeding
- Current use of permanent contraception (has had a hysterectomy, tubal permanent contraception, or partner with a vasectomy in the last month)
- Use of any contraceptive pills, patches, vaginal rings or any contraceptive implant or IUD use in the last 4 weeks
- Use of oral emergency contraception in last 5 days
- Vaginal bleeding of unknown etiology
- Use of injectable hormonal contraceptive (Depo-Provera) in the last 6 months
- Planned use of any non-contraceptive estrogen, progesterone, or testosterone
- Acute cervicitis
- Known abnormalities of the uterus that distort the uterine cavity
- Ended pregnancy at or under 20 weeks gestational age within the last 2 weeks
- Ended pregnancy over 20 weeks gestational age within the last 6 weeks
The study team makes the final eligibility decision.
Where it's taking place
- San Jose, California, United States
- Denver, Colorado, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Saint Paul, Minnesota, United States
- Portland, Oregon, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 16 years to 35 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Jose, California, United States; Denver, Colorado, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Saint Paul, Minnesota, United States; Portland, Oregon, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.