Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162611
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2023-11-30
Brief Title:
Etonogestrel ENG Implant Insertion for Emergency Contraception With Oral Levonorgestrel LNG vs Placebo
Sponsor:
Lori Gawron
Organization:
University of Utah
Study Overview
Official Title:
Generating Evidence to Improve Same-day Etonogestrel ENG Implant Insertion for Emergency Contraception
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 35 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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None