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

Conditions

• Contraception

Eligibility Criteria

Sex

FEMALE

Age

16 Years - 35 Years

Healthy Volunteers

Not accepted

Interventions

• Levonorgestrel 52 MG Intrauterine System — DRUG
  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.

Study Details

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.

Key Dates

Start date

Nov 7, 2022

Status verified

Apr 2026

Primary completion

Mar 31, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

1,404 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: 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.

Primary Outcome Measure

Number of pregnancies reported in participants at one month post insertion of IUD [ Time Frame: One Month ]

Central Contacts

• Corinne Sexsmith
  801-213-2522
  [email protected]
• Sarah Elliott, MPH
  [email protected]

Locations (8)

Find similar trials in San Jose, CA

Related Studies

• Evaluation of the Efficacy, Safety, and Tolerability of LevoCept
  PHASE3 · Not Yet Recruiting · Sebela Women's Health Inc. · Berkeley, California
• Etonogestrel Implant as Emergency Contraception
  PHASE4 · Recruiting · University of Colorado, Denver · Aurora, Colorado
• Endometrial Biopsy in Progestin Contraceptive Users
  EARLY_PHASE1 · Recruiting · Oregon Health and Science University · Portland, Oregon
• Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years
  Recruiting · Emory University · Boston, Massachusetts