NCT02267616

Brief Summary

This study will evaluate LNG-IUD and Etonogestrel (ENG) Implant users who are willing to use their contraception beyond the end of the FDA-approved duration. ENG Implant users will also be offered to participate in an arm of the study that will randomize them to either keeping their implant in or having it removed and replaced with a new implant. Participants will be followed for up to three years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,076

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

April 15, 2021

Status Verified

February 1, 2021

Enrollment Period

9.3 years

First QC Date

October 14, 2014

Last Update Submit

April 12, 2021

Conditions

Contraception

Keywords

Levonorgestrel intrauterine device (LNG IUD)Etonogestrel (ENG) ImplantContraception

Outcome Measures

Primary Outcomes (1)

  • Effectiveness

    Our primary aim is to test the absolute and relative effectiveness of both the LNG-IUD and the ENG implant in a non-inferiority (equivalence) study comparing failure rates of these methods in the 3 years post-FDA approved duration to the failure rates during the first three years.

    Three years

Secondary Outcomes (3)

  • Unintended pregnancy rates

    Three years

  • Time to contraceptive failure

    Three years

  • Randomized trial analysis

    Three years

Study Arms (3)

Continued Use Implant Group

EXPERIMENTAL

Woman randomly assigned to the continued use of their Etonogestrel Implant will continue to use their Etonogestrel Implant for contraception past FDA-approved duration of 36 months.

Device: Etonogestrel Implant

New Implant Group

ACTIVE COMPARATOR

Woman randomly assigned to the new Etonogestrel Implant will have their existing Etonogestrel Implant removed and a new implant placed.

Device: Etonogestrel Implant

Observational Continued Use Group

NO INTERVENTION

Women who refuse randomization will have an option of continuing to use their existing Etonogestrel Implant beyond the FDA-approved duration (36 months).

Interventions

Etonogestrel ImplantDEVICE

Subdermal arm implant

Continued Use Implant GroupNew Implant Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women age 18-45
  • Within 6 months of expiration or beyond the end of the FDA-approved duration of use of the levonorgestrel intrauterine device (LNG-IUD = 5 years) OR the etonogestrel-releasing subdermal implant (ENG implant = 3 years)
  • Able to consent in English or Spanish.
  • Not pregnant at the time of enrollment

You may not qualify if:

  • Have history of female sterilization procedure
  • Desire for conception in the next 12 months
  • Not sexually active with a male partner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Washington University in St. Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (12)

  • Henshaw SK. Unintended pregnancy in the United States. Fam Plann Perspect. 1998 Jan-Feb;30(1):24-9, 46.

    PMID: 9494812BACKGROUND

  • Singh S, Sedgh G, Hussain R. Unintended pregnancy: worldwide levels, trends, and outcomes. Stud Fam Plann. 2010 Dec;41(4):241-50. doi: 10.1111/j.1728-4465.2010.00250.x.

    PMID: 21465725BACKGROUND

  • Goodman S, Hendlish SK, Benedict C, Reeves MF, Pera-Floyd M, Foster-Rosales A. Increasing intrauterine contraception use by reducing barriers to post-abortal and interval insertion. Contraception. 2008 Aug;78(2):136-42. doi: 10.1016/j.contraception.2008.03.008. Epub 2008 Jun 18.

    PMID: 18672115BACKGROUND

  • ACOG Committee Opinion no. 450: Increasing use of contraceptive implants and intrauterine devices to reduce unintended pregnancy. Obstet Gynecol. 2009 Dec;114(6):1434-1438. doi: 10.1097/AOG.0b013e3181c6f965.

    PMID: 20134301BACKGROUND

  • Peipert JF, Zhao Q, Allsworth JE, Petrosky E, Madden T, Eisenberg D, Secura G. Continuation and satisfaction of reversible contraception. Obstet Gynecol. 2011 May;117(5):1105-1113. doi: 10.1097/AOG.0b013e31821188ad.

    PMID: 21508749BACKGROUND

  • Mosher WD, Jones J. Use of contraception in the United States: 1982-2008. Vital Health Stat 23. 2010 Aug;(29):1-44.

    PMID: 20939159BACKGROUND

  • Kiriwat O, Patanayindee A, Koetsawang S, Korver T, Bennink HJ. A 4-year pilot study on the efficacy and safety of Implanon, a single-rod hormonal contraceptive implant, in healthy women in Thailand. Eur J Contracept Reprod Health Care. 1998 Jun;3(2):85-91. doi: 10.3109/13625189809051409.

    PMID: 9710712BACKGROUND

  • Trussell J. Update on the cost-effectiveness of contraceptives in the United States. Contraception. 2010 Oct;82(4):391. doi: 10.1016/j.contraception.2010.04.008. Epub 2010 May 18. No abstract available.

    PMID: 20851236BACKGROUND

  • Trussell J, Lalla AM, Doan QV, Reyes E, Pinto L, Gricar J. Cost effectiveness of contraceptives in the United States. Contraception. 2009 Jan;79(1):5-14. doi: 10.1016/j.contraception.2008.08.003. Epub 2008 Sep 25.

    PMID: 19041435BACKGROUND

  • Bahamondes L, Faundes A, Sobreira-Lima B, Lui-Filho JF, Pecci P, Matera S. TCu 380A IUD: a reversible permanent contraceptive method in women over 35 years of age. Contraception. 2005 Nov;72(5):337-41. doi: 10.1016/j.contraception.2004.12.026. Epub 2005 Jul 18.

    PMID: 16246658BACKGROUND

  • Makarainen L, van Beek A, Tuomivaara L, Asplund B, Coelingh Bennink H. Ovarian function during the use of a single contraceptive implant: Implanon compared with Norplant. Fertil Steril. 1998 Apr;69(4):714-21. doi: 10.1016/s0015-0282(98)00015-6.

    PMID: 9548163BACKGROUND

  • Huber J, Wenzl R. RETRACTED: Pharmacokinetics of Implanon. An integrated analysis. Contraception. 1998 Dec;58(6 Suppl):85S-90S. doi: 10.1016/s0010-7824(98)00120-6.

    PMID: 10095978BACKGROUND

Related Links

Study Officials

  • Jeffrey F Peipert, MD, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This study will evaluate the use of the Etonogestrel Implant or hormonal intrauterine device (IUD) for contraception past the FDA approved duration. The Etonogestrel Implant is currently approved for 3 years of use, and the hormonal IUD is currently approved for 5 years.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Clarence E. Ehrlich Professor; Chair, Dept of Obstetrics and Gynecology

Study Record Dates

First Submitted

October 14, 2014

First Posted

October 17, 2014

Study Start

December 1, 2011

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

April 15, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)