CompletedNot Applicable

Same Day Oral EC and Implant Initiation

United States306 participantsStarted 2021-02-17

Plain-language summary

This is a study for clients presenting for emergency contraception (EC). EC is used to prevent pregnancy after unprotected intercourse. Clients presenting for EC may be offered either the copper or hormonal IUD or oral EC. Current guidelines allow for same-day implant initiation at the time of an EC encounter, as long as oral LNG EC is co-administered. This study will look at pregnancy rates and clients willingness to receive same-day implant + oral EC and same-day IUDs.

Who can participate

Age range

18 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy women * Age 18-35 years * Fluent in English and/or Spanish * BMI \< 30 kg/m2 * No known contraindication to either the ENG contraceptive implant or oral LNG EC using the CDC Medical Eligibility Criteria for Contraceptive Use 2016 * Negative urine pregnancy test * Willing to abstain from further UPI in the 7 days following insertion * Know the date of their last menstrual period * Regular menstrual cycle (24-35 days) * Be willing to comply with the study requirements * Desiring to avoid pregnancy for at least 12 months Exclusion Criteria: * Current pregnancy or breastfeeding * Previous use of oral EC in the current cycle * Report of UPI beyond 5 days in current cycle * Vaginal bleeding of unknown etiology * Allergy to LNG or ENG, IUD or implant in-place * History of permanent contraception through sterilization or hysterectomy * Monogamous partner with a vasectomy * Depo-provera injection within past 15 weeks

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pregnancy Rate at One-month

Timeframe: one month

Comparing Proportions of EC Clients Desiring ENG Implant With Oral EC vs IUD

Timeframe: 2 years

Trial details

NCT IDNCT04678817

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-04-27

Results submitted2024-09-18

View on ClinicalTrials.gov More Contraception trials