ContraceptionPhase 4LNG-IUSNCT02121067

LNG-IUS at 2 Weeks Postpartum

A Phase 4 study testing Levonorgestrel Intrauterine System (LNG-IUS) in people with Contraception and Malposition of Intrauterine Contraceptive Device, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Contraception, Malposition of Intrauterine Contraceptive Device
What is being tested?: Levonorgestrel Intrauterine System (LNG-IUS)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Sep 2014to Jun 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Desiring a LNG-IUS
Postpartum, ages 18-45 who deliver at a gestational age > 32 weeks, delivery can be via cesarean or vaginal delivery
Following a viable, singleton pregnancy
Willing to return to UNC for their LNG-IUS insertion and study follow-up
Who plan to stay in the UNC area for 6 months and willing to return to UNC for 3 visits
Fluent in English or Spanish
At risk of repeat pregnancy (i.e. excluding those who had tubal sterilization)

Who cannot join

No genital bleeding of unknown etiology
No personal history of known or suspected breast carcinoma
No 4th degree vaginal laceration at time of delivery
No documented uterine rupture during delivery
No active liver disease (resolved pre-eclampsia may enroll)
No evidence of vaginal, cervical or uterine infection at time of LNG-IUS insertion

Show all 12Show fewer

No history of postpartum endometritis treated with antibiotics or a postpartum readmission for a dilation and curettage
No pre-existing contraindication to a LNG-IUS as determined by the CDC's Medical Eligibility Criteria (MEC) category 3 or 4
Not currently incarcerated
No known congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity
No suspected hypersensitivity or contraindication to the LNG-IUS
With any other condition or circumstance that the PI determines could cause an adverse event or interfere with completing the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: Intrauterine Contraceptive Insertion at Two-weeks Postpartum: A Study of Acceptability and Short-term Outcomes

This is a study of 50 postpartum women interested in having the Mirena® LNG-IUS placed for contraception. The Mirena® is an FDA approved intrauterine contraceptive device that provides contraception for 5 years with excellent effectiveness. Women enrolled in this study will only have the Mirena® placed at two-weeks postpartum (day 14-20 postpartum). The participants will be followed at 6-weeks and 6-months postpartum for study visits to evaluate for satisfaction, symptoms, expulsion, and perforation. The study will be completed at six-months postpartum, and participants will be able to keep their LNG-IUS following study completion.

Conditions: Contraception, Malposition of Intrauterine Contraceptive Device
Being tested: Levonorgestrel Intrauterine System (LNG-IUS)
Keywords: postpartum, contraception, intrauterine device, intrauterine system, mirena, uterine involution

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Levonorgestrel Intrauterine System (LNG-IUS)Drug
Also called Mirena
The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled

Study groups in NCT02121067
Study group	Role	What they receive
LNG-IUS placed at 2 weeks postpartum	Experimental	Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum Receives: Drug: Levonorgestrel Intrauterine System (LNG-IUS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum.
A dichotomous, yes/no answer to the following question "Would you recommend Mirena placement at two-weeks postpartum to a friend?"
Measured: 6 months postpartum
Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion in the 2 Week (Day 14-20) Postpartum Period.
Was the LNG-IUS successfully placed in the study period, as determined by whether the participant had an LNG-IUS placed on the day of insertion?
Measured: Day 14-20 postpartum

Secondary outcomes (1)

Number of Participants With Expulsion (Complete or Partial) of LNG-IUS at Six-months.
Expulsion will be defined as any of the following (1) patient report that the LNG-IUS came out, (2) ultrasound evaluation that demonstrates the LNG-IUS is not intrauterine (3) ultrasound or clinical evaluation that demonstrates the majority of the LNG-IUS is located in the cervix.
Measured: 6 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Jun 2016

First posted23 Apr 2014 (estimated)
Study startSep 2014
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ContraceptionStudies of the same condition, open and under way.
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: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02121067
Sponsor's protocol ID: 14-0202
Acronym: LNG-IUS
Status last verified: Jul 2017
First submitted: 24 Mar 2014
Last updated: 24 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Zerden ML, Stuart GS, Charm S, Bryant A, Garrett J, Morse J. Two-week postpartum intrauterine contraception insertion: a study of feasibility, patient acceptability and short-term outcomes. Contraception. 2017 Jan;95(1):65-70. doi: 10.1016/j.contraception.2016.08.005. Epub 2016 Aug 20.
PubMed 27554014

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intrauterine Contraceptive Insertion at Two-weeks Postpartum: A Study of Acceptability and Short-term Outcomes
ClinicalTrials.gov ID: NCT02121067
Acronym / sponsor ID: LNG-IUS / 14-0202
Conditions: Contraception, Malposition of Intrauterine Contraceptive Device
Keywords: postpartum, contraception, intrauterine device, intrauterine system, mirena, uterine involution
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: Society of Family Planning
Study start: Sep 2014
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 23 Apr 2014 (estimated)
Results: Posted 1 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LNG-IUS placed at 2 weeks postpartum	Experimental	Drug: Levonorgestrel Intrauterine System (LNG-IUS)Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Desiring a LNG-IUS
Postpartum, ages 18-45 who deliver at a gestational age > 32 weeks, delivery can be via cesarean or vaginal delivery
Following a viable, singleton pregnancy
Willing to return to UNC for their LNG-IUS insertion and study follow-up
Who plan to stay in the UNC area for 6 months and willing to return to UNC for 3 visits

Key exclusion criteria (12 listed)

No genital bleeding of unknown etiology
No personal history of known or suspected breast carcinoma
No 4th degree vaginal laceration at time of delivery
No documented uterine rupture during delivery
No active liver disease (resolved pre-eclampsia may enroll)

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
Levonorgestrel Intrauterine System (LNG-IUS)Also: MirenaThe LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled	Drug	LNG-IUS placed at 2 weeks postpartum

Primary outcome

Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum.
Time frame: 6 months postpartum
A dichotomous, yes/no answer to the following question "Would you recommend Mirena placement at two-weeks postpartum to a friend?"
Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion in the 2 Week (Day 14-20) Postpartum Period.
Time frame: Day 14-20 postpartum
Was the LNG-IUS successfully placed in the study period, as determined by whether the participant had an LNG-IUS placed on the day of insertion?

1 secondary outcome

Number of Participants With Expulsion (Complete or Partial) of LNG-IUS at Six-months.
Time frame: 6 months postpartum

Results and safety

Results posted to the registry on 1 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LNG-IUS Placed at 2 Weeks Postpartum	50	50

Primary outcome: Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum.

Time frame: 6 months postpartum. Count of participants. Unit: Participants

Measure	LNG-IUS Placed at 2 Weeks Postpartum n = 43
Value	40

Population analysed: Of the 50 participants who enrolled, only 43 were available at 6 months postpartum to provide data for the first primary outcome.

Primary outcome: Number of Participants Who Enrolled and Were Able to Have a Successful LNG-IUS Insertion in the 2 Week (Day 14-20) Postpartum Period.

Time frame: Day 14-20 postpartum. Count of participants. Unit: Participants

Measure	LNG-IUS Placed at 2 Weeks Postpartum n = 50
Value	50

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LNG-IUS Placed at 2 Weeks Postpartum	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27554014Zerden ML, Stuart GS, Charm S, Bryant A, Garrett J, Morse J. Two-week postpartum intrauterine contraception insertion: a study of feasibility, patient acceptability and short-term outcomes. Contraception. 2017 Jan;95(1):65-70. doi: 10.1016/j.contraception.2016.08.005. Epub 2016 Aug 20.

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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.

Matthew L Zerden, MD, MPH principal investigator

UNCH

Gretchen S Stuart, MD study director

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 12 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 24 Aug 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Who Would Recommend the LNG-IUS to a Friend at 6-months Postpartum. (time frame: 6 months postpartum). The study lists 2 primary outcomes in all. 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 NCT02121067, which also lists 1 linked publication.

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 24 Aug 2017; AzTrials last refreshed its copy on 27 Oct 2026.