NCT02414919

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13,880

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

April 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 13, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2016

Completed
Last Updated

March 16, 2017

Status Verified

March 1, 2017

Enrollment Period

12 months

First QC Date

April 8, 2015

Last Update Submit

March 14, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of women who use HERC

    2 years post-HERC initiation

Secondary Outcomes (1)

  • Duration of real world use of three different HERC devices

    2 years post-HERC initiation

Other Outcomes (3)

  • Difference in patient characteristics of women who chose different HERC devices

    2 years post-HERC initiation

  • Proportion of HERC used for ≥3 years of duration

    ≥3 years post-HERC initiation

  • Model the predictors of ≥3 years of duration

    ≥3 years post-HERC initiation

Study Arms (1)

HERC

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

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

Interventions

Levonorgestrel-releasing intrauterine device 20 mcg/day

HERC

Copper T380A

HERC

Etonorgestrel contraceptive implant

HERC

Eligibility Criteria

Age15 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Salt Lake City, Utah, United States

Location

Related Publications (3)

  • 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

    BACKGROUND
  • 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.

  • 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.

    RESULT

MeSH Terms

Interventions

Levonorgestreletonogestrel

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 13, 2015

Study Start

April 1, 2015

Primary Completion

March 28, 2016

Study Completion

March 28, 2016

Last Updated

March 16, 2017

Record last verified: 2017-03

Locations