Effectiveness of Prolonged Use of IUD/Implant for Contraception

Contraception Clinical Trial

— EPIC  

Official title:

Effectiveness of Prolonged Use of IUD/Implant for Contraception

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267616
• Other study ID #: 1603304047
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: March 31, 2021

Study information

• Verified date: February 2021
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1076
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Have history of female sterilization procedure

• Desire for conception in the next 12 months

• Not sexually active with a male partner

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• Etonogestrel Implant
Subdermal arm implant

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana
United States	Washington University in St. Louis School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Susan Thompson Buffett Foundation

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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. Epub 2005 Jul 18. — View Citation

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. — View Citation

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

Huber J, Wenzl R. Pharmacokinetics of Implanon. An integrated analysis. Contraception. 1998 Dec;58(6 Suppl):85S-90S. Erratum in: Contraception 1999 Feb;59(2):145. Retraction in: Rekers H, Affandi B. Contraception. 2004 Nov;70(5):433. — View Citation

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. — View Citation

Mäkäräinen 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. — View Citation

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

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. — View Citation

Singh S, Sedgh G, Hussain R. Unintended pregnancy: worldwide levels, trends, and outcomes. Stud Fam Plann. 2010 Dec;41(4):241-50. — View Citation

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. Erratum in: Contraception. 2009 Aug;80(2):229-30. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   Contraceptive technology. 19th rev. ed. New York, N.Y.: Ardent Media; 2007.
•   Institute of Medicine (US). Initial national priorities for comparative effectiveness research. Washington, DC: National Academies Press; 2009.