Emergency ContraceptionPhase 4NCT06162611
Etonogestrel (ENG) Implant Insertion for Emergency Contraception With Oral Levonorgestrel (LNG) vs Placebo
A Phase 4 study testing Etonogestrel implant with Oral Levonorgestrel emergency contraception 1.5mg in people with Emergency Contraception, run by Lori Gawron at 1 site in United States.
Trial summary
Intrauterine devices (IUDs) are highly effective to prevent pregnancy when used for emergency contraception (following unprotected intercourse in the last 3 days), but data are lacking for people who desire an etonogestrel (ENG) contraceptive implant in this situation. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Emergency Contraception
- What is being tested?
- Etonogestrel implant with Oral Levonorgestrel emergency contraception 1.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 790 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2023to 31 May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18-35 years old
- Unprotected intercourse within 72 hours
- Biologically capable of pregnancy (intact uterus without prior sterilization surgery
- Fluent in English and/or Spanish
- Have a regular menstrual cycle (21-35 days)
- Known last menstrual period (+/- 3 days)
Show all 9Show fewer
- Working (cell) phone number
- Willing to comply with the study requirements
- Willing to abstain from any CYP3A4 inducer for 5 days
Who cannot join
- Current pregnancy (+urine pregnancy test in clinic)
- Breastfeeding
- Contraindication to ENG or LNG based on CDC MEC/SPR
- Sterilization, hysterectomy, or has an IUD or contraceptive implant in place
- Vaginal bleeding of unknown etiology
- Previous use of EC in same cycle
Show all 14Show fewer
- Allergy to LNG or ENG
- History of intolerance/ side effects with ENG Implant
- Current (past 7 days) use of any CYP3A4 inducer
- Plan to use any other steroid hormone in the next 4 weeks (testosterone, estrogen, progesterone)
- Ended a pregnancy at or under 20 weeks gestational age within last 2 weeks
- Ended a pregnancy over 20 weeks gestational age in last 6 weeks
- Use of any injectable hormonal contraceptive (Depo-Provera) in the last 15 weeks
- Use of any oral EC, contraceptive pills, patches, vaginal rings, or an IUD or Implant in the last 2 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Planned Parenthood Association of Utah
Salt Lake City, Utah, 84102
Corinne Sexsmith
David Turok, MD, MPH
About this study
Official title: Generating Evidence to Improve Same-day Etonogestrel (ENG) Implant Insertion for Emergency Contraception
Intrauterine devices (IUDs) are highly effective to prevent pregnancy when used for emergency contraception (following unprotected intercourse in the last 3 days), but data are lacking for people who desire an etonogestrel (ENG) contraceptive implant in this situation. This proposal will identify the most effective way to start an implant for emergency contraception using a randomized controlled trial comparing pregnancy risk between those receiving the implant vs. the implant plus oral emergency contraception (EC). Data from this project will inform clinical practice and add another option, the implant, for those desiring a long acting, highly effective contraceptive method when they present for emergency contraception.
Read the detailed description
Oral emergency contraception (EC), is commonly used after recent unprotected intercourse to avoid undesired pregnancy, but does not provide ongoing contraception. Rigorous data allow for use of intrauterine devices (IUDs) as both EC and ongoing contraception, but EC efficacy data on use of the etonogestrel (ENG) implant, is lacking. The CDC Selected Practice Recommendations for Contraceptive Use support initiation of the ENG implant if oral levonorgestrel (LNG) is given concomitantly for EC. This recommendation lacks supporting evidence and serves as a barrier to method initiation, as oral LNG is not typically available in clinics when clients desire an implant. Additionally, oral LNG efficacy decreases in higher body mass index (BMI) users and the role of BMI on efficacy with co-administered oral LNG and the ENG implant is unknown. As the ENG implant is also a synthetic progestogen with a rapid rise and consistent systemic levels, it could plausibly serve as stand-alone EC or increase the efficacy of oral LNG with co-administration. Moreover, the EC mechanism of action, which is related to ovulatory suppression with oral EC, may differ if the implant is initiated with or without oral LNG, impacting efficacy in mid cycle users. This study addresses the following research gaps around use of the ENG implant for EC that serve as barriers to provider comfort with these options: efficacy with and without oral LNG, efficacy differences by BMI, and ovulation frequency with and without oral LNG. The investigators propose a randomized, placebo-controlled, non-inferiority study to determine if the ENG implant alone is no worse than the ENG implant + oral LNG for EC, using a 3.5% non-inferiority margin. The investigators will include clients who present to Planned Parenthood Association of Utah clinics with report of unprotected intercourse within 72 hours who desire EC. Eligible EC clients interested in an implant with a negative pregnancy test will be allocated 1:1 to a study group: (1) ENG implant + oral LNG or (2) ENG implant + placebo. Our experienced research staff will follow up with participants for 4-week efficacy data as primary outcome. Our aims include: (1) To compare the efficacy of the ENG Implant + oral LNG to the ENG Implant + placebo for EC in 790 participants assessed by pregnancy status four weeks after implant placement, (2) To compare pregnancy risk by BMI category (the investigators anticipate half of the 790 participants will have a BMI ≥25) between and within the ENG Implant + oral LNG and the ENG Implant + placebo groups, and (3) To evaluate ovulation frequency within 5 days of insertion of ENG Implant + oral LNG or ENG implant + placebo in 202 participants who are mid cycle (day 7-14 post menses) at time of enrollment assessed by serum progesterone levels and urine fertility monitor results. Our short-term goal is to expand evidence on the efficacy of implant initiation with or without oral LNG to meet the needs of EC clients. Our long-term goals are to develop evidence-based clinical guidelines to inform global contraceptive practices, allow for equity in long acting reversible contraception counseling at the time of EC, and support reproductive autonomy for people to achieve to their life goals.
- Conditions
- Emergency Contraception
- Being tested
- Etonogestrel implant with Oral Levonorgestrel emergency contraception 1.5mg, Etonogestrel implant with oral placebo
- Keywords
- contraception, etonogestrel implant, oral levonorgestrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etonogestrel implant with Oral Levonorgestrel emergency contraception 1.5mgDrug
Single pill of oral levonorgestrel 1.5mg X 1 dose (e.g. Plan B) same day as contraceptive implant insertion
Etonogestrel implant with oral placeboDevice
Single pill of placebo same day as contraceptive implant insertion
| Study group | Role | What they receive |
|---|---|---|
| Etonogestrel contraceptive implant with oral levonorgestrel | Active comparator | Patients will be randomized 1:1 to each arm and will receive the contraceptive implant with a same-day encapsulated pill with either oral levonorgestrel 1.5mg Receives: Drug: Etonogestrel implant with Oral Levonorgestrel emergency contraception 1.5mg |
| Etonogestrel contraceptive implant with placebo | Placebo comparator | Patients will be randomized 1:1 to each arm and will receive the contraceptive implant with a same-day encapsulated pill with placebo X 1 dose Receives: Device: Etonogestrel implant with oral placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the etonogestrel contraceptive implant with placebo for emergency contraception
Pregnancy rate = number of pregnancies / participants in the placebo arm
Measured: 1 month after enrollment
Efficacy of the etonogestrel contraceptive implant with placebo for emergency contraception by BMI category
Pregnancy rate = # of pregnancies / participants in the placebo arm stratified by BMI category
Measured: 1 month after enrollment
Efficacy of the etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception
Pregnancy rate = # of pregnancies / participants in the oral levonorgestrel arm
Measured: 1 month after enrollment
Efficacy of the etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception by BMI category
Pregnancy rate = # of pregnancies / participants in the oral levonorgestrel arm stratified by BMI category
Measured: 1 month after enrollment
Ovulation frequency within 5 days of implant insertion in the oral levonorgestrel arm
Incidence of ovulation within 5 days after implant insertion measured by urine fertility monitor results and serum progesterone
Measured: 5 days after implant insertion
Ovulation frequency within 5 days of implant insertion in the placebo arm
Incidence of ovulation within 5 days after implant insertion measured by urine fertility monitor results and serum progesterone
Measured: 5 days after implant insertion
Secondary outcomes (2)
Implant continuation
Participants continuing implant use at one month as a proportion of all participants having successful placement of implant at study entry. Measured by probabilities estimated using Kaplan-Meier approach.
Measured: 4 weeks after insertion
Implant satisfaction
Likelihood of satisfaction by study group using ordinal regression. Measured by 5-point ordinal scale (5-point ordinal scale: (1) very unsatisfied, (2) unsatisfied, (3) neutral, (4) satisfied, (5) very satisfied). Measured by
Measured: 4 weeks after insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start6 Nov 2023
- Primary completion30 Apr 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial of the etonogestrel contraceptive implant randomized to same day oral levonorgestrel or placebo in emergency contraception patients
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 790 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lori Gawron
- Sponsor type
- University, hospital or other
- Collaborators
- Planned Parenthood Association of Utah
- Responsible party
- Sponsor-investigator, Lori Gawron, University of Utah
- Investigators
- Lori Gawron, MD, MPH, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162611
- Sponsor's protocol ID
- 00152448
- Status last verified
- May 2026
- First submitted
- 30 Nov 2023
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generating Evidence to Improve Same-day Etonogestrel (ENG) Implant Insertion for Emergency Contraception
- ClinicalTrials.gov ID
- NCT06162611
- Acronym / sponsor ID
- 00152448
- Conditions
- Emergency Contraception
- Keywords
- contraception, etonogestrel implant, oral levonorgestrel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 790 participants (estimated)
- Lead sponsor
- Lori GawronUniversity, hospital or other
- Collaborators
- Planned Parenthood Association of Utah
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intrauterine devices (IUDs) are highly effective to prevent pregnancy when used for emergency contraception (following unprotected intercourse in the last 3 days), but data are lacking for people who desire an etonogestrel (ENG) contraceptive implant in this situation. This proposal will identify the most effective way to start an implant for emergency contraception using a randomized controlled trial comparing pregnancy risk between those receiving the implant vs. the implant plus oral emergency contraception (EC). Data from this project will inform clinical practice and add another option, the implant, for those desiring a long acting, highly effective contraceptive method when they present for emergency contraception.
Detailed description
Oral emergency contraception (EC), is commonly used after recent unprotected intercourse to avoid undesired pregnancy, but does not provide ongoing contraception. Rigorous data allow for use of intrauterine devices (IUDs) as both EC and ongoing contraception, but EC efficacy data on use of the etonogestrel (ENG) implant, is lacking. The CDC Selected Practice Recommendations for Contraceptive Use support initiation of the ENG implant if oral levonorgestrel (LNG) is given concomitantly for EC. This recommendation lacks supporting evidence and serves as a barrier to method initiation, as oral LNG is not typically available in clinics when clients desire an implant. Additionally, oral LNG efficacy decreases in higher body mass index (BMI) users and the role of BMI on efficacy with co-administered oral LNG and the ENG implant is unknown. As the ENG implant is also a synthetic progestogen with a rapid rise and consistent systemic levels, it could plausibly serve as stand-alone EC or increase the efficacy of oral LNG with co-administration. Moreover, the EC mechanism of action, which is related to ovulatory suppression with oral EC, may differ if the implant is initiated with or without oral LNG, impacting efficacy in mid cycle users. This study addresses the following research gaps around use of the ENG implant for EC that serve as barriers to provider comfort with these options: efficacy with and without oral LNG, efficacy differences by BMI, and ovulation frequency with and without oral LNG. The investigators propose a randomized, placebo-controlled, non-inferiority study to determine if the ENG implant alone is no worse than the ENG implant + oral LNG for EC, using a 3.5% non-inferiority margin. The investigators will include clients who present to Planned Parenthood Association of Utah clinics with report of unprotected intercourse within 72 hours who desire EC. Eligible EC clients interested in an implant with a negative pregnancy test will be allocated 1:1 to a study group: (1) ENG implant + oral LNG or (2) ENG implant + placebo. Our experienced research staff will follow up with participants for 4-week efficacy data as primary outcome. Our aims include: (1) To compare the efficacy of the ENG Implant + oral LNG to the ENG Implant + placebo for EC in 790 participants assessed by pregnancy status four weeks after implant placement, (2) To compare pregnancy risk by BMI category (the investigators anticipate half of the 790 participants will have a BMI ≥25) between and within the ENG Implant + oral LNG and the ENG Implant + placebo groups, and (3) To evaluate ovulation frequency within 5 days of insertion of ENG Implant + oral LNG or ENG implant + placebo in 202 participants who are mid cycle (day 7-14 post menses) at time of enrollment assessed by serum progesterone levels and urine fertility monitor results. Our short-term goal is to expand evidence on the efficacy of implant initiation with or without oral LNG to meet the needs of EC clients. Our long-term goals are to develop evidence-based clinical guidelines to inform global contraceptive practices, allow for equity in long acting reversible contraception counseling at the time of EC, and support reproductive autonomy for people to achieve to their life goals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial of the etonogestrel contraceptive implant randomized to same day oral levonorgestrel or placebo in emergency contraception patients
| Arm | Type | Receives |
|---|---|---|
| Etonogestrel contraceptive implant with oral levonorgestrel | Active comparator | Drug: Etonogestrel implant with Oral Levonorgestrel emergency contraception 1.5mgPatients will be randomized 1:1 to each arm and will receive the contraceptive implant with a same-day encapsulated pill with either oral levonorgestrel 1.5mg |
| Etonogestrel contraceptive implant with placebo | Placebo comparator | Device: Etonogestrel implant with oral placeboPatients will be randomized 1:1 to each arm and will receive the contraceptive implant with a same-day encapsulated pill with placebo X 1 dose |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Between 18-35 years old
- Unprotected intercourse within 72 hours
- Biologically capable of pregnancy (intact uterus without prior sterilization surgery
- Fluent in English and/or Spanish
- Have a regular menstrual cycle (21-35 days)
Key exclusion criteria (14 listed)
- Current pregnancy (+urine pregnancy test in clinic)
- Breastfeeding
- Contraindication to ENG or LNG based on CDC MEC/SPR
- Sterilization, hysterectomy, or has an IUD or contraceptive implant in place
- Vaginal bleeding of unknown etiology
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 implant with Oral Levonorgestrel emergency contraception 1.5mgSingle pill of oral levonorgestrel 1.5mg X 1 dose (e.g. Plan B) same day as contraceptive implant insertion | Drug | Etonogestrel contraceptive implant with oral levonorgestrel |
| Etonogestrel implant with oral placeboSingle pill of placebo same day as contraceptive implant insertion | Device | Etonogestrel contraceptive implant with placebo |
Primary outcome
Efficacy of the etonogestrel contraceptive implant with placebo for emergency contraception
Time frame: 1 month after enrollment
Pregnancy rate = number of pregnancies / participants in the placebo arm
Efficacy of the etonogestrel contraceptive implant with placebo for emergency contraception by BMI category
Time frame: 1 month after enrollment
Pregnancy rate = # of pregnancies / participants in the placebo arm stratified by BMI category
Efficacy of the etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception
Time frame: 1 month after enrollment
Pregnancy rate = # of pregnancies / participants in the oral levonorgestrel arm
Efficacy of the etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception by BMI category
Time frame: 1 month after enrollment
Pregnancy rate = # of pregnancies / participants in the oral levonorgestrel arm stratified by BMI category
Ovulation frequency within 5 days of implant insertion in the oral levonorgestrel arm
Time frame: 5 days after implant insertion
Incidence of ovulation within 5 days after implant insertion measured by urine fertility monitor results and serum progesterone
Ovulation frequency within 5 days of implant insertion in the placebo arm
Time frame: 5 days after implant insertion
Incidence of ovulation within 5 days after implant insertion measured by urine fertility monitor results and serum progesterone
2 secondary outcomes
Implant continuation
Time frame: 4 weeks after insertion
Implant satisfaction
Time frame: 4 weeks after insertion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Lori Gawron, MD, MPH principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etonogestrel implant with Oral Levonorgestrel emergency contraception 1.5mg in people with Emergency Contraception, run by Lori Gawron at 1 site 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 9 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corinne Sexsmith, MPH (801-213-2419, corinne.sexsmith@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the etonogestrel contraceptive implant with placebo for emergency contraception (time frame: 1 month after enrollment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2026.