Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Susan Thompson Buffett Foundation | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This prospective cohort study will evaluate 675 LNG-IUD users and 675 Etonogestrel (ENG) Implant users who are within 6 months of expiration or beyond the end of the FDA-approved duration. Participants will be contacted via telephone and either scheduled to enroll in person or be mailed the consent form before participation in the EPIC study. After the signed consent form is obtained, participants will also be asked to complete a brief telephone or in-person questionnaire on sociodemographic, medical and reproductive history, sexual and contraceptive history, history of unintended pregnancy and substance abuse. During the informed consent process, implant users will also be offered to participate in an arm of the study that will randomize them (if they consent) to either keeping their subdermal implant in or have it removed and replaced with a new subdermal implant. The randomized control trial subset allows us to compare effectiveness to that of a new implant.
It also allows us to assess "other contraceptive use" (e.g. condom use) in both groups.
Participants will also be asked if they are interested in providing a blood sample for analysis of etonogestrel assay levels at baseline enrollment and annually. If Follow-up phone interviews will occur every 6 months for 36 months beyond the expiration of their method. The investigators will attempt to validate all pregnancy outcomes with medical chart reviews.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etonogestrel Implant | Device | Subdermal arm implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Unintended pregnancy rates | The contraceptive failure (unintended pregnancy) rates for the LNG-IUD and ENG implant users at 12, 24, and 36 months (after FDA-approved duration of use: 5 years for LNG IUD and 3 years for the ENG implant) of the contraceptive method will be compared to those for CHC users. | Three years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey F Peipert, MD, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States | ||
| Washington University in St. Louis School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9494812 | Background | Henshaw SK. Unintended pregnancy in the United States. Fam Plann Perspect. 1998 Jan-Feb;30(1):24-9, 46. | |
| 21465725 | Background | 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. |
| Label | URL |
|---|---|
| Institute of Medicine (US). Initial national priorities for comparative effectiveness research. Washington, DC: National Academies Press; 2009. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 14, 2022 | |
| Reset | Aug 10, 2022 | |
| Release | Aug 10, 2023 | |
| Reset | Mar 7, 2024 | |
| Release | May 3, 2025 | |
| Reset | May 20, 2025 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 14, 2022 | Aug 10, 2022 | |||
| Aug 10, 2023 |
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.
Not provided
Not provided
Not provided
Not provided
| Time to contraceptive failure |
we will use Kaplan-Meier curves to describe the distribution of time to contraceptive failure for the LNG-IUD and ENG implant users compared to combined hormonal contraceptive users (control). |
| Three years |
| Randomized trial analysis | An identical analysis will be performed using the "intention-to-treat" principle (i.e. analyze the participant according to the assigned group as determined by randomization). | Three years |
| St Louis |
| Missouri |
| 63110 |
| United States |
| 18672115 | Background | 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. |
| 20134301 | Background | 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. |
| 21508749 | Background | 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. |
| 20939159 | Background | Mosher WD, Jones J. Use of contraception in the United States: 1982-2008. Vital Health Stat 23. 2010 Aug;(29):1-44. |
| 9710712 | Background | 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. |
| 20851236 | Background | 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. |
| 19041435 | Background | 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. |
| 16246658 | Background | 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. |
| 9548163 | Background | 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. |
| 10095978 | Background | 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. |
|
| Contraceptive technology. 19th rev. ed. New York, N.Y.: Ardent Media; 2007. | View source |
| Mar 7, 2024 |
| May 3, 2025 | May 20, 2025 |