Trial Outcomes & Findings for Same Day Oral EC and Implant Initiation (NCT NCT04678817)

Last Updated: 2025-04-15

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

306 participants

Primary outcome timeframe

one month

Results posted on

2025-04-15

Participant Flow

Emergency contraception clients age 18-35y at four Utah family planning clinics between February 2021 and April 2023 received information about oral emergency contraception and three long acting reversible contraception options: the etonogestrel implant with same-day oral levonogestrel, the 52mf levonogestrel intrauterine device, and the copper T380A intrauterine device.

We excluded nine potential participants for long acting reversible contraception contraindications and another four due to failed intrauterine device insertions

Participant milestones

Participant milestones
Measure	Etonogestrel Contraceptive Implant With Oral Levonorgestrel Participants who select the Etonogestrel implant with oral levonorgestrel for emergency contraception Etonogestrel contraceptive implant with oral levonorgestrel: Participants who present for emergency contraception and select the Etonogestrel contraceptive implant with oral levonorgestrel	Levonorgestrel Intrauterine Device Participants who select the levonorgestrel intrauterine device for emergency contraception Levonorgestrel intrauterine device: Participants who present for emergency contraception and select the Levonorgestrel intrauterine device	Copper T380A Intrauterine Device Participants who select the Copper T380A intrauterine device for emergency contraception Copper T380A intrauterine device: Participants who present for emergency contraception and select the Copper T380A intrauterine device
Overall Study STARTED	160	61	72
Overall Study COMPLETED	132	61	72
Overall Study NOT COMPLETED	28	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Etonogestrel Contraceptive Implant With Oral Levonorgestrel Participants who select the Etonogestrel implant with oral levonorgestrel for emergency contraception Etonogestrel contraceptive implant with oral levonorgestrel: Participants who present for emergency contraception and select the Etonogestrel contraceptive implant with oral levonorgestrel	Levonorgestrel Intrauterine Device Participants who select the levonorgestrel intrauterine device for emergency contraception Levonorgestrel intrauterine device: Participants who present for emergency contraception and select the Levonorgestrel intrauterine device	Copper T380A Intrauterine Device Participants who select the Copper T380A intrauterine device for emergency contraception Copper T380A intrauterine device: Participants who present for emergency contraception and select the Copper T380A intrauterine device
Overall Study Lost to Follow-up	28	0	0

Baseline Characteristics

Same Day Oral EC and Implant Initiation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etonogestrel Contraceptive Implant With Oral Levonorgestrel n=160 Participants Participants who select the Etonogestrel implant with oral levonorgestrel for emergency contraception Etonogestrel contraceptive implant with oral levonorgestrel: Participants who present for emergency contraception and select the Etonogestrel contraceptive implant with oral levonorgestrel	Levonorgestrel Intrauterine Device n=61 Participants Participants who select the levonorgestrel intrauterine device for emergency contraception Levonorgestrel intrauterine device: Participants who present for emergency contraception and select the Levonorgestrel intrauterine device	Copper T380A Intrauterine Device n=72 Participants Participants who select the Copper T380A intrauterine device for emergency contraception Copper T380A intrauterine device: Participants who present for emergency contraception and select the Copper T380A intrauterine device	Total n=293 Participants Total of all reporting groups
Age, Customized <20 years	41 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	59 Participants n=4 Participants
Age, Customized 20-24 years	72 Participants n=5 Participants	30 Participants n=7 Participants	28 Participants n=5 Participants	130 Participants n=4 Participants
Age, Customized 25-29 years	24 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants	48 Participants n=4 Participants
Age, Customized 30+ years	23 Participants n=5 Participants	14 Participants n=7 Participants	19 Participants n=5 Participants	56 Participants n=4 Participants
Sex: Female, Male Female	160 Participants n=5 Participants	61 Participants n=7 Participants	72 Participants n=5 Participants	293 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Black/ African American	9 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	13 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic/ Latina	80 Participants n=5 Participants	15 Participants n=7 Participants	16 Participants n=5 Participants	111 Participants n=4 Participants
Race/Ethnicity, Customized Race not listed	14 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	21 Participants n=4 Participants
Race/Ethnicity, Customized White	57 Participants n=5 Participants	39 Participants n=7 Participants	52 Participants n=5 Participants	148 Participants n=4 Participants
Region of Enrollment United States	160 participants n=5 Participants	61 participants n=7 Participants	72 participants n=5 Participants	293 participants n=4 Participants
Body mass index < 25 kg/m2	71 Participants n=5 Participants	30 Participants n=7 Participants	47 Participants n=5 Participants	148 Participants n=4 Participants
Body mass index 25 - 29.9 kg/m2	36 Participants n=5 Participants	18 Participants n=7 Participants	15 Participants n=5 Participants	69 Participants n=4 Participants
Body mass index 30+ kg/m2	53 Participants n=5 Participants	12 Participants n=7 Participants	9 Participants n=5 Participants	74 Participants n=4 Participants
Body mass index missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: one month

Population: Participants who selected the Etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception reported pregnancy test results at 1 month post enrollment. Participants who selected a Levonorgestrel Intrauterine Device or a Copper T380A Intrauterine Device only completed an enrollment survey and were not followed for longitudinal outcomes.

Outcome measures

Outcome measures
Measure	Etonogestrel Contraceptive Implant With Oral Levonorgestrel n=153 Participants Participants who selected the Etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception	Levonorgestrel Intrauterine Device Participants who select the levonorgestrel intrauterine device for emergency contraception Levonorgestrel intrauterine device: Participants who present for emergency contraception and select the Levonorgestrel intrauterine device	Copper T380A Intrauterine Device Participants who select the Copper T380A intrauterine device for emergency contraception Copper T380A intrauterine device: Participants who present for emergency contraception and select the Copper T380A intrauterine device
Pregnancy Rate at One-month	1.96 percentage of participants Interval 0.51 to 6.07	—	—

PRIMARY outcome

Timeframe: 2 years

Population: Number of participants choosing each method out of total 293 enrolled

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.

Outcome measures

Outcome measures
Measure	Etonogestrel Contraceptive Implant With Oral Levonorgestrel n=160 Participants Participants who selected the Etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception	Levonorgestrel Intrauterine Device n=61 Participants Participants who select the levonorgestrel intrauterine device for emergency contraception Levonorgestrel intrauterine device: Participants who present for emergency contraception and select the Levonorgestrel intrauterine device	Copper T380A Intrauterine Device n=72 Participants Participants who select the Copper T380A intrauterine device for emergency contraception Copper T380A intrauterine device: Participants who present for emergency contraception and select the Copper T380A intrauterine device
Comparing Proportions of EC Clients Desiring ENG Implant With Oral EC vs IUD	54.6 percentage of participants	20.8 percentage of participants	24.6 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Number of participants from Arm 1 who selected an etonogestrel implant and completed a 12 month follow up survey. The outcome measure below is the percentage who reported implant continuation at 12 months. Participants who selected a Levonorgestrel Intrauterine Device or a Copper T380A Intrauterine Device only completed an enrollment survey and were not followed for longitudinal outcomes.

12-month continuation rate of the ENG implant with same-day initiation at an EC encounter.

Outcome measures

Outcome measures
Measure	Etonogestrel Contraceptive Implant With Oral Levonorgestrel n=132 Participants Participants who selected the Etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception	Levonorgestrel Intrauterine Device Participants who select the levonorgestrel intrauterine device for emergency contraception Levonorgestrel intrauterine device: Participants who present for emergency contraception and select the Levonorgestrel intrauterine device	Copper T380A Intrauterine Device Participants who select the Copper T380A intrauterine device for emergency contraception Copper T380A intrauterine device: Participants who present for emergency contraception and select the Copper T380A intrauterine device
Continuation Rate	79 Participants	—	—

SECONDARY outcome

Timeframe: 12 months

Population: Number of participants from Arm 1 who selected an etonogestrel implant and reported discontinuation of the implant in the 12 months of follow up survey.s The outcome measures below are the percentage who reported reasons for method implant discontinuation. More than 1 reason could be selected by participants. Participants who selected a Levonorgestrel Intrauterine Device or a Copper T380A Intrauterine Device only completed an enrollment survey and were not followed for longitudinal outcomes.

Rate and reasons for ENG implant discontinuation in the 12 months following same-day initiation at an EC encounter.

Outcome measures

Outcome measures
Measure	Etonogestrel Contraceptive Implant With Oral Levonorgestrel n=53 Participants Participants who selected the Etonogestrel contraceptive implant with oral levonorgestrel for emergency contraception	Levonorgestrel Intrauterine Device Participants who select the levonorgestrel intrauterine device for emergency contraception Levonorgestrel intrauterine device: Participants who present for emergency contraception and select the Levonorgestrel intrauterine device	Copper T380A Intrauterine Device Participants who select the Copper T380A intrauterine device for emergency contraception Copper T380A intrauterine device: Participants who present for emergency contraception and select the Copper T380A intrauterine device
Discontinuation Rate and Reasons Discontinued for mood changes	41 percentage of participants	—	—
Discontinuation Rate and Reasons Discontinued for bleeding	51 percentage of participants	—	—
Discontinuation Rate and Reasons Discontinued for weight gain	37 percentage of participants	—	—
Discontinuation Rate and Reasons Discontinued for bloating	24 percentage of participants	—	—
Discontinuation Rate and Reasons Discontinued for cramping	20 percentage of participants	—	—

Adverse Events

Etonogestrel Contraceptive Implant With Oral Levonorgestrel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Levonorgestrel Intrauterine Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Copper T380A Intrauterine Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lori Gawron, MD

University of Utah

Phone: 801-213-4989

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place