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Levonorgestrel 52 mg IUD for Emergency Contraception and Same-Day Start

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor 2 versions Re-verified since Apr 1, 2026, no change to tracked fieldsv12-v13
  2. Minor Site details revised at 1 of 8 sitesv11
  3. Notable Primary completion date: Aug 31, 2026 to Mar 31, 2027v10
  4. Notable Phase: Not specified to Phase 4 Primary completion date: Jul 31, 2025 to Aug 31, 2026 · Completion date: Oct 31, 2025 to Jul 31, 2027 · Start date: Nov 8, 2022 to Nov 7, 2022 · 1 morev9 Show 4 more changesShow less
    • Primary completion date: Jul 31, 2025 to Aug 31, 2026
    • Completion date: Oct 31, 2025 to Jul 31, 2027
    • Start date: Nov 8, 2022 to Nov 7, 2022
    • Study description expanded, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  5. Minor Eligibility criteria expanded, about 32 wordsv8 See this version in full on ClinicalTrials.gov ↗
Show 6 earlier versionsHide 6 earlier versions
  1. Minor Eligibility criteria shortened, about 3 wordsv7 See this version in full on ClinicalTrials.gov ↗
  2. Minor Enrollment target: 1235 to 1404v6
  3. Minor Site details revised at 4 of 8 sitesv5
  4. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 15, 2022 to Nov 8, 2022 · Site details revised at 8 of 8 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of Nov 15, 2022 to Nov 8, 2022
    • Site details revised at 8 of 8 sites
  5. Minor Eligibility criteria expanded, about 26 wordsv3 See this version in full on ClinicalTrials.gov ↗
  6. Notable Start date: Aug 15, 2022 to Nov 15, 2022 Eligibility criteria expanded, about 10 wordsv2 Show 1 more changeShow less
    • Eligibility criteria expanded, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. The study population will include people initiating an LNG 52 mg IUD and meet inclusion and exclusion criteria at 8 Planned Parenthood affiliates nationwide. Planned Parenthood Federation of America was the first major healthcare organization to change its practice to incorporate the changes we are studying here. As such, all study participants will be offered the opportunity to choose the interventional IUD at the site they visit. The primary outcome is pregnancy status one month after LNG IUD placement by home urine pregnancy test or clinical record review. Participant follow up concludes one month after enrollment. The purpose of this study is to demonstrate reproducibility of earlier findings in a more heterogenous population. As such, IUD placement is not a study procedure but a component of clinical care. The study interventions only involve study participation and provision of data around the use of the levonorgestrel 52 mg IUD for EC or same day start.
Trial Details
NCT Number NCT05444582
Lead Sponsor University of Utah
Collaborators: Planned Parenthood Federation of America
Conditions Contraception
Enrollment 1,404 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov