- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02414919
Duration of Use of Highly Effective Reversible Contraception
March 14, 2017 updated by: Bayer
Real-world Duration of Use for Highly Effective Reversible Contraception (HERC): A Retrospective Review
To assess the proportion of women who use HERC for ≥2 years of duration
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
13880
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
-
Salt Lake, Utah, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 44 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women who had an IUD or contraceptive implant inserted at the University of Utah healthcare system
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HERC
Women who had an insertion of HERC (Mirena IUD, ParaGard IUD, Implanon or Nexplanon)
|
Levonorgestrel-releasing intrauterine device 20 mcg/day
Copper T380A
Etonorgestrel contraceptive implant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of women who use HERC
Time Frame: 2 years post-HERC initiation
|
2 years post-HERC initiation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of real world use of three different HERC devices
Time Frame: 2 years post-HERC initiation
|
2 years post-HERC initiation
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Difference in patient characteristics of women who chose different HERC devices
Time Frame: 2 years post-HERC initiation
|
2 years post-HERC initiation
|
Proportion of HERC used for ≥3 years of duration
Time Frame: ≥3 years post-HERC initiation
|
≥3 years post-HERC initiation
|
Model the predictors of ≥3 years of duration
Time Frame: ≥3 years post-HERC initiation
|
≥3 years post-HERC initiation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2015
Primary Completion (ACTUAL)
March 28, 2016
Study Completion (ACTUAL)
March 28, 2016
Study Registration Dates
First Submitted
April 8, 2015
First Submitted That Met QC Criteria
April 8, 2015
First Posted (ESTIMATE)
April 13, 2015
Study Record Updates
Last Update Posted (ACTUAL)
March 16, 2017
Last Update Submitted That Met QC Criteria
March 14, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17714
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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