Effectiveness of Prolonged Use of IUD/Implant for Contraception
NCT ID: NCT02267616
Last Updated: 2021-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1076 participants
INTERVENTIONAL
2011-12-31
2021-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Continued Use Implant Group
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.
Etonogestrel Implant
Subdermal arm implant
New Implant Group
Woman randomly assigned to the new Etonogestrel Implant will have their existing Etonogestrel Implant removed and a new implant placed.
Etonogestrel Implant
Subdermal arm implant
Observational Continued Use Group
Women who refuse randomization will have an option of continuing to use their existing Etonogestrel Implant beyond the FDA-approved duration (36 months).
No interventions assigned to this group
Interventions
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Etonogestrel Implant
Subdermal arm implant
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Desire for conception in the next 12 months
* Not sexually active with a male partner
18 Years
45 Years
FEMALE
Yes
Sponsors
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Susan Thompson Buffett Foundation
UNKNOWN
Indiana University
OTHER
Responsible Party
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Jeffrey Peipert
The Clarence E. Ehrlich Professor; Chair, Dept of Obstetrics and Gynecology
Principal Investigators
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Jeffrey F Peipert, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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Indiana University
Indianapolis, Indiana, United States
Washington University in St. Louis School of Medicine
St Louis, Missouri, United States
Countries
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References
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Henshaw SK. Unintended pregnancy in the United States. Fam Plann Perspect. 1998 Jan-Feb;30(1):24-9, 46.
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.
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.
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.
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.
Mosher WD, Jones J. Use of contraception in the United States: 1982-2008. Vital Health Stat 23. 2010 Aug;(29):1-44.
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.
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.
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.
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.
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.
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.
Related Links
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Institute of Medicine (US). Initial national priorities for comparative effectiveness research. Washington, DC: National Academies Press; 2009.
Contraceptive technology. 19th rev. ed. New York, N.Y.: Ardent Media; 2007.
Other Identifiers
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1603304047
Identifier Type: -
Identifier Source: org_study_id
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