RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-11-07
Study Completion:2027-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05444582

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 35 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Meet clinic eligibility for IUD placement
  2. * 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
  3. * Negative high sensitivity urine pregnancy test prior to IUD placement.
  4. * No known contraindications to the LNG 52 mg IUD per the CDC Medical Eligibility Criteria for Contraceptive Use 2016
  5. * 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.
  6. * Fluent in English or Spanish
  7. * Working Cell Phone number that receives text messages
  8. * 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
  1. * Current pregnancy
  2. * Currently Breastfeeding
  3. * Current use of permanent contraception (has had a hysterectomy, tubal permanent contraception, or partner with a vasectomy in the last month)
  4. * Use of any contraceptive pills, patches, vaginal rings or any contraceptive implant or IUD use in the last 4 weeks
  5. * Use of oral emergency contraception in last 5 days
  6. * Vaginal bleeding of unknown etiology
  7. * Use of injectable hormonal contraceptive (Depo-Provera) in the last 6 months
  8. * Planned use of any non-contraceptive estrogen, progesterone, or testosterone
  9. * Acute cervicitis
  10. * Known abnormalities of the uterus that distort the uterine cavity
  11. * Ended pregnancy at or under 20 weeks gestational age within the last 2 weeks
  12. * Ended pregnancy over 20 weeks gestational age within the last 6 weeks

Contacts and Locations

Study Contact

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

Principal Investigator

David Turok, MD, MPH
PRINCIPAL_INVESTIGATOR
University of Utah

Study Locations (Sites)

Planned Parenthood Mar Monte
San Jose, California, 95126
United States
Planned Parenthood of the Rocky Mountains
Denver, Colorado, 80207
United States
Planned Parenthood Illinoi
Chicago, Illinois, 60603
United States
Planned Parenthood League of Massachusetts
Boston, Massachusetts, 02215
United States
Planned Parenthood North Central States
Saint Paul, Minnesota, 55114
United States
Planned Parenthood Columbia Willamette
Portland, Oregon, 97212
United States
Planned Parenthood Association of Utah
Salt Lake City, Utah, 84102
United States
Planned Parenthood Great Northwest Hawaii, Alaska, Indiana, Kentucky
Seattle, Washington, 98122
United States

Collaborators and Investigators

Sponsor: University of Utah

  • David Turok, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-07
Study Completion Date2027-07-31

Study Record Updates

Study Start Date2022-11-07
Study Completion Date2027-07-31

Terms related to this study

Keywords Provided by Researchers

  • Emergency Contraception
  • IUD

Additional Relevant MeSH Terms

  • Contraception