ContraceptionNCT04678817
Same Day Oral EC and Implant Initiation
An observational study of Contraception, run by University of Utah at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Etonogestrel contraceptive implant with oral levonorgestrel, Levonorgestrel intrauterine device and Copper T380A intrauterine device
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 306 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Feb 2021to 15 Mar 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Study population will be recruited from participating Planned Parenthood of Utah clinics.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Planned Parenthood Association of Utah
Salt Lake City, Utah, 84102
Planned Parenthood Association of Utah
West Valley City, Utah, 84119
About this study
Official title: A Prospective Observational Study of Preference for and Efficacy of Oral Levonorgestrel Emergency Contraception With Same Day Etonogestrel Contraceptive Implant Compared to Established Pregnancy Rates With Oral Levonorgestrel Emergency Contraception Alone
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.
Read the detailed description
Recommended options for EC include oral EC (levonorgestrel (LNG), ulipristal acetate (UPA), or combination oral contraceptive pills), or the copper intrauterine device (IUD). Recent data will also allow women presenting for EC to be offered the LNG IUD. These recommendations leave out the only other long-acting reversible contraceptive (LARC), the ENG implant. Current guidelines allow for same-day ENG implant initiation at the time of an EC encounter, as long as oral LNG EC is co-administered. We lack data on pregnancy risk for the EC-eligible population desiring same-day ENG implant placement and oral EC.
Women presenting for EC often need ongoing contraception, but clinical practice is not standardized in same-day counseling and initiation due to system, provider, and client-level barriers. Interest in LARC use continues to increase as well as same-day contraception initiation at the time of an EC encounter. Women presenting for EC may not have considered LARC options before. Generating estimates and continuation rates for same-day initiation with an EC encounter will improve contraceptive options for women seeking EC.
- Conditions
- Contraception
- Being tested
- Etonogestrel contraceptive implant with oral levonorgestrel, Levonorgestrel intrauterine device, Copper T380A intrauterine device
- Keywords
- emergency contraception, contraceptive implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etonogestrel contraceptive implant with oral levonorgestrelDevice
Participants who present for emergency contraception and select the Etonogestrel contraceptive implant with oral levonorgestrel
Levonorgestrel intrauterine deviceDevice
Participants who present for emergency contraception and select the Levonorgestrel intrauterine device
Copper T380A intrauterine deviceDevice
Participants who present for emergency contraception and select the Copper T380A intrauterine device
| Study group | Role | What they receive |
|---|---|---|
| Etonogestrel contraceptive implant with oral levonorgestrel | Participants who select the Etonogestrel implant with oral levonorgestrel for emergency contraception Receives: Device: Etonogestrel contraceptive implant with oral levonorgestrel | |
| Levonorgestrel intrauterine device | Participants who select the levonorgestrel intrauterine device for emergency contraception Receives: Device: Levonorgestrel intrauterine device | |
| Copper T380A intrauterine device | Participants who select the Copper T380A intrauterine device for emergency contraception Receives: Device: Copper T380A intrauterine device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Rate at One-month
To determine a point estimate for the one-month pregnancy rate following guideline supported same-day initiation of an etonogestrel (ENG) implant plus oral levonorgestrel (LNG) emergency contraception (EC).
Measured: one month
Comparing Proportions of EC Clients Desiring ENG Implant With Oral EC vs IUD
To determine the proportion of EC clients willing to initiate a same-day ENG implant with oral LNG EC compared to same-day initiation of intrauterine devices for EC.
Measured: 2 years
Secondary outcomes (2)
Continuation Rate
12-month continuation rate of the ENG implant with same-day initiation at an EC encounter.
Measured: 12 months
Discontinuation Rate and Reasons
Rate and reasons for ENG implant discontinuation in the 12 months following same-day initiation at an EC encounter.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start17 Feb 2021
- Primary completion27 Apr 2023
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lori Gawron, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678817
- Sponsor's protocol ID
- 137011
- Status last verified
- Apr 2025
- First submitted
- 16 Dec 2020
- Last updated
- 15 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be available to share with other researchers.
Publications
Carter G, Pangasa M, Sexsmith CD, Elliott S, Turok DK, Gawron LM. Selection of long acting reversible contraception methods by emergency contraception clients: A prospective observational study. Contraception. 2025 Jan;141:110701. doi: 10.1016/j.contraception.2024.110701. Epub 2024 Sep 4.
PubMed 39241904Gawron LM, Sexsmith CD, Carter G, Kaiser JE, Pangasa M, Turok DK. Efficacy of oral levonorgestrel emergency contraception with same day etonogestrel contraceptive implant: A prospective observational study. Contraception. 2024 Mar;131:110344. doi: 10.1016/j.contraception.2023.110344. Epub 2023 Nov 25.
PubMed 38008305
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Preference for and Efficacy of Oral Levonorgestrel Emergency Contraception With Same Day Etonogestrel Contraceptive Implant Compared to Established Pregnancy Rates With Oral Levonorgestrel Emergency Contraception Alone
- ClinicalTrials.gov ID
- NCT04678817
- Acronym / sponsor ID
- 137011
- Conditions
- Contraception
- Keywords
- emergency contraception, contraceptive implant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 22 Dec 2020 (actual)
- Results
- Posted 15 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recommended options for EC include oral EC (levonorgestrel (LNG), ulipristal acetate (UPA), or combination oral contraceptive pills), or the copper intrauterine device (IUD). Recent data will also allow women presenting for EC to be offered the LNG IUD. These recommendations leave out the only other long-acting reversible contraceptive (LARC), the ENG implant. Current guidelines allow for same-day ENG implant initiation at the time of an EC encounter, as long as oral LNG EC is co-administered. We lack data on pregnancy risk for the EC-eligible population desiring same-day ENG implant placement and oral EC.
Women presenting for EC often need ongoing contraception, but clinical practice is not standardized in same-day counseling and initiation due to system, provider, and client-level barriers. Interest in LARC use continues to increase as well as same-day contraception initiation at the time of an EC encounter. Women presenting for EC may not have considered LARC options before. Generating estimates and continuation rates for same-day initiation with an EC encounter will improve contraceptive options for women seeking EC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Etonogestrel contraceptive implant with oral levonorgestrel | – | Device: Etonogestrel contraceptive implant with oral levonorgestrelParticipants who select the Etonogestrel implant with oral levonorgestrel for emergency contraception |
| Levonorgestrel intrauterine device | – | Device: Levonorgestrel intrauterine deviceParticipants who select the levonorgestrel intrauterine device for emergency contraception |
| Copper T380A intrauterine device | – | Device: Copper T380A intrauterine deviceParticipants who select the Copper T380A intrauterine device for emergency contraception |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Study population will be recruited from participating Planned Parenthood of Utah clinics.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etonogestrel contraceptive implant with oral levonorgestrelParticipants who present for emergency contraception and select the Etonogestrel contraceptive implant with oral levonorgestrel | Device | Etonogestrel contraceptive implant with oral levonorgestrel |
| Levonorgestrel intrauterine deviceParticipants who present for emergency contraception and select the Levonorgestrel intrauterine device | Device | Levonorgestrel intrauterine device |
| Copper T380A intrauterine deviceParticipants who present for emergency contraception and select the Copper T380A intrauterine device | Device | Copper T380A intrauterine device |
Primary outcome
Pregnancy Rate at One-month
Time frame: one month
To determine a point estimate for the one-month pregnancy rate following guideline supported same-day initiation of an etonogestrel (ENG) implant plus oral levonorgestrel (LNG) emergency contraception (EC).
Comparing Proportions of EC Clients Desiring ENG Implant With Oral EC vs IUD
Time frame: 2 years
To determine the proportion of EC clients willing to initiate a same-day ENG implant with oral LNG EC compared to same-day initiation of intrauterine devices for EC.
2 secondary outcomes
Continuation Rate
Time frame: 12 months
Discontinuation Rate and Reasons
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39241904Carter G, Pangasa M, Sexsmith CD, Elliott S, Turok DK, Gawron LM. Selection of long acting reversible contraception methods by emergency contraception clients: A prospective observational study. Contraception. 2025 Jan;141:110701. doi: 10.1016/j.contraception.2024.110701. Epub 2024 Sep 4.
- Derived from this study: PubMed 38008305Gawron LM, Sexsmith CD, Carter G, Kaiser JE, Pangasa M, Turok DK. Efficacy of oral levonorgestrel emergency contraception with same day etonogestrel contraceptive implant: A prospective observational study. Contraception. 2024 Mar;131:110344. doi: 10.1016/j.contraception.2023.110344. Epub 2023 Nov 25.
- Individual participant dataSharing planned: No. Individual participant data will not be available to share with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Gawron, MD principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception, run by University of Utah at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Rate at One-month (time frame: one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04678817, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.