PregnancyNCT02414919
Duration of Use of Highly Effective Reversible Contraception
An observational study of Pregnancy, run by Bayer at 1 site in United States.
Trial summary
To assess the proportion of women who use HERC for ≥2 years of duration Read more about this study
- Who is it for?
- Ages 15 to 44 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Mirena (Levonorgestrel IUS, BAY86-5028), ParaGard and Implanon/Nexplanon
- How many people
- 13,880 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2015to 28 Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 44 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Women who had an IUD or contraceptive implant inserted at the University of Utah healthcare system
Who may be able to join
- -Women who had an IUD or contraceptive implant inserted and removed within the University of Utah from January 1, 2004 to October 31, 2012
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Pregnancy
- Being tested
- Mirena (Levonorgestrel IUS, BAY86-5028), ParaGard, Implanon/Nexplanon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirena (Levonorgestrel IUS, BAY86-5028)Drug
Levonorgestrel-releasing intrauterine device 20 mcg/day
ParaGardDrug
Copper T380A
Implanon/NexplanonDrug
Etonorgestrel contraceptive implant
| Study group | Role | What they receive |
|---|---|---|
| HERC | Women who had an insertion of HERC (Mirena IUD, ParaGard IUD, Implanon or Nexplanon) Receives: Drug: Mirena (Levonorgestrel IUS, BAY86-5028); Drug: ParaGard; Drug: Implanon/Nexplanon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women who use HERC
Measured: 2 years post-HERC initiation
Secondary outcomes (1)
Duration of real world use of three different HERC devices
Measured: 2 years post-HERC initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2015 (estimated)
- Study start1 Apr 2015
- Primary completion28 Mar 2016
- Study completion28 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13,880 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Utah
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414919
- Sponsor's protocol ID
- 17714
- Status last verified
- Mar 2017
- First submitted
- 8 Apr 2015
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
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 28188772Sanders 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 at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Duration of Use for Highly Effective Reversible Contraception (HERC): A Retrospective Review
- ClinicalTrials.gov ID
- NCT02414919
- Acronym / sponsor ID
- 17714
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,880 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- University of Utah
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 28 Mar 2016 (actual)
- Study completion
- 28 Mar 2016 (actual)
- First posted
- 13 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the proportion of women who use HERC for ≥2 years of duration
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HERC | – | Drug: Mirena (Levonorgestrel IUS, BAY86-5028), Drug: ParaGard, Drug: Implanon/NexplanonWomen who had an insertion of HERC (Mirena IUD, ParaGard IUD, Implanon or Nexplanon) |
Who may qualify
- Ages
- 15 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Women who had an IUD or contraceptive implant inserted at the University of Utah healthcare system
Key inclusion criteria (1 listed)
- -Women who had an IUD or contraceptive implant inserted and removed within the University of Utah from January 1, 2004 to October 31, 2012
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirena (Levonorgestrel IUS, BAY86-5028)Levonorgestrel-releasing intrauterine device 20 mcg/day | Drug | HERC |
| ParaGardCopper T380A | Drug | HERC |
| Implanon/NexplanonEtonorgestrel contraceptive implant | Drug | HERC |
Primary outcome
Proportion of women who use HERC
Time frame: 2 years post-HERC initiation
1 secondary outcome
Duration of real world use of three different HERC devices
Time frame: 2 years post-HERC initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- BackgroundSanders 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
- Results publication: PubMed 28188772Sanders 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.
- Results publicationSanders 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women who use HERC (time frame: 2 years post-HERC initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02414919, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.