CClinicalTrials.gg
CompletedNCT02414919Updated Mar 16, 2017

Duration of Use of Highly Effective Reversible Contraception

An observational study in Pregnancy, sponsored by Bayer. Completed at 1 site in United States. Open to female participants aged 15 Years to 44 Years. Per ClinicalTrials.gov, last updated 2017-03-16.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
13,880
Ages
15 Years to 44 Years
Sex
Female
01

Study summary

To assess the proportion of women who use HERC for ≥2 years of duration

02

Conditions studied

  • Pregnancy
03

In context

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women who had an IUD or contraceptive implant inserted at the University of Utah healthcare system

Eligibility criteria

Inclusion Criteria:

-Women who had an IUD or contraceptive implant inserted and removed within the University of Utah from January 1, 2004 to October 31, 2012

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
13,880 participants (actual)

Groups and cohorts

  • HERC

    Women who had an insertion of HERC (Mirena IUD, ParaGard IUD, Implanon or Nexplanon)

    Drug: Mirena (Levonorgestrel IUS, BAY86-5028) · Drug: ParaGard · Drug: Implanon/Nexplanon

Interventions

  • DrugMirena (Levonorgestrel IUS, BAY86-5028)

    Levonorgestrel-releasing intrauterine device 20 mcg/day

  • DrugParaGard

    Copper T380A

  • DrugImplanon/Nexplanon

    Etonorgestrel contraceptive implant

06

What researchers measure

Primary outcomes

  1. Proportion of women who use HERC

    Time frame: 2 years post-HERC initiation

Secondary outcomes

  1. Duration of real world use of three different HERC devices

    Time frame: 2 years post-HERC initiation

Other outcomes

  1. Difference in patient characteristics of women who chose different HERC devices

    Time frame: 2 years post-HERC initiation

  2. Proportion of HERC used for ≥3 years of duration

    Time frame: ≥3 years post-HERC initiation

  3. Model the predictors of ≥3 years of duration

    Time frame: ≥3 years post-HERC initiation

07

Study locations

1 site
  • Salt Lake, Utah, United States
08

References and documents

Publications

  • Sanders J, Turok D, Gawron L, Law A, Wen L, Lynen R. Continuation of Long-Acting Reversible Contraception at Two Years in a University Healthcare Setting: A Retrospective Review. JMCP 2016;22(4a):S126
  • Sanders JN, Turok DK, Gawron LM, Law A, Wen L, Lynen R. Two-year continuation of intrauterine devices and contraceptive implants in a mixed-payer setting: a retrospective review. Am J Obstet Gynecol. 2017 Jun;216(6):590.e1-590.e8. doi: 10.1016/j.ajog.2017.02.003. Epub 2017 Feb 8. PubMed 28188772 ↗
  • Sanders J, Turok D, Gawron L, Law A, Wen L, Lynen R. Three-Year Continuation of Long-Acting Reversible Contraceptive methods in a Mixed-Payer Health Care Setting: A Retrospective Review. Contraception 2016;94:405-406.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02414919
Lead sponsor
Bayer
Collaborators
University of Utah
Responsible party
Sponsor
First posted
Apr 13, 2015
Start date
Apr 1, 2015
Primary completion
Mar 28, 2016
Completion
Mar 28, 2016
Last update
Mar 16, 2017

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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