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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05444582
Recruitment Status : Not yet recruiting
First Posted : July 6, 2022
Last Update Posted : November 7, 2022
Sponsor:
Collaborator:
Planned Parenthood Federation of America
Information provided by (Responsible Party):
University of Utah

Brief Summary:

This is a pragmatic prospective observational 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 receive the standard of care at the site they visit which is not the standard of care by most sexual and reproductive healthcare providers. 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 care that is being provided at the clinical sites, including insertion of the LNG IUD is standard per this practice group. 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. We provide the IND information as it applies even though this is not a FDA phased clinical trial.


Condition or disease Intervention/treatment
Contraception Drug: Levonorgestrel 52 MG Intrauterine System

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Study Type : Observational
Estimated Enrollment : 1235 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Levonorgestrel 52 mg IUD for Emergency Contraception and Same-Day Start
Estimated Study Start Date : November 15, 2022
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : October 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Group/Cohort Intervention/treatment
Observational: 52 mg LNG IUD Same Day Start or EC

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.

Drug: Levonorgestrel 52 MG Intrauterine System

Eligible participants must be 16-35 years old, meet clinic eligibility for IUD placement, and having 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 intercourse in the last 5 days.





Primary Outcome Measures :
  1. Number of pregnancies reported in participants at one month post insertion of IUD [ Time Frame: One Month ]
    Positive pregnancies reported by participants through survey and photo of pregnancy test one month after LNG IUD placement by home urine pregnancy test or clinical record review.


Secondary Outcome Measures :
  1. Percentage of participants continuing to use IUD at one month post insertion [ Time Frame: One Month ]
    Percentage of participants continuing to use IUD at one month post insertion



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Females, aged 16-35 presenting for care and initiating a levonorgestrel (LNG) 52 mg IUD in three distinct clinical situations.
Criteria

Inclusion 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 intercourse in the last 5 days
  • 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
  • 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

Exclusion Criteria:

  • 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)
  • Current use of an IUD or contraceptive implant
  • Use of any contraceptive pills, patches or vaginal rings 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05444582


Contacts
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Contact: Corinne Sexsmith 801-213-2522 corinne.sexsmith@hsc.utah.edu
Contact: Sarah Elliott, MPH sarah.elliott@hsc.utah.edu

Locations
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United States, California
Planned Parenthood Mar Monte
San Jose, California, United States, 95126
Contact: Corinne Sexsmith       corinne.sexsmith@hsc.utah.edu   
United States, Colorado
Planned Parenthood of the Rocky Mountains
Denver, Colorado, United States, 80207
Contact: Corinne Sexsmith       corinne.sexsmith@hsc.utah.edu   
United States, Illinois
Planned Parenthood Illinoi
Chicago, Illinois, United States, 60603
Contact: Corinne Sexsmith       corinne.sexsmith@hsc.utah.edu   
United States, Massachusetts
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States, 02215
Contact: Corinne Sexsmith       corinne.sexsmith@hsc.utah.edu   
United States, Minnesota
Planned Parenthood North Central States
Saint Paul, Minnesota, United States, 55114
Contact: Corinne Sexsmith       corinne.sexsmith@hsc.utah.edu   
United States, Oregon
Planned Parenthood Columbia Willamette
Portland, Oregon, United States, 97212
Contact: Corinne Sexsmith       corinne.sexsmith@hsc.utah.edu   
United States, Utah
Planned Parenthood Association of Utah
Salt Lake City, Utah, United States, 84102
United States, Washington
Planned Parenthood Great Northwest Hawaii, Alaska, Indiana, Kentucky
Seattle, Washington, United States, 98122
Contact: Corinne Sexsmith       corinne.sexsmith@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Planned Parenthood Federation of America
Investigators
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Principal Investigator: David Turok, MD, MPH University of Utah
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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT05444582    
Other Study ID Numbers: 00151440
First Posted: July 6, 2022    Key Record Dates
Last Update Posted: November 7, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Utah:
Emergency Contraception
IUD
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes
Levonorgestrel
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral