CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Levonorgestrel Intrauterine System (LNG-IUS)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02121067
NCT02121067Phase 4Completed

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

University of North Carolina, Chapel Hill·interventional·Posted Apr 23, 2014·Updated Aug 24, 2017

In Brief

A Phase 4 clinical trial evaluating Levonorgestrel Intrauterine System (LNG-IUS) for Contraception and Malposition of Intrauterine Contraceptive Device. Completed, enrolled 50 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 23, 2014
Enrollment StartSep 1, 2014
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.2 years ago

Interventions

Levonorgestrel Intrauterine System (LNG-IUS)drug

The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled