Phase 4
N=23
Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT00653159 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Retention Rate — 55; 75 percentage of randomized subjects — p=0.4003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Levonorgestrel-releasing intrauterine device (LNG-IUS) (Device); Copper T380A intrauterine device (CuT380A) (Device)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- Female
- Sponsor
- University of Chicago
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention Rate |
55; 75 | 0.4003 |
| SECONDARY Heavy Bleeding Rates |
55; 33 | 0.4136 |
| SECONDARY Pregnancy Rates |
9; 0 | 0.4783 |
| SECONDARY Expulsion Rates |
18; 0 | 0.2174 |
| SECONDARY Device Satisfaction Rates |
80; 70 | 1.0000 |
Summary
This is a pilot study to determine the feasibility for a randomized controlled trial of two forms of intrauterine contraception: the Levonorgestrel intrauterine system (LNG-IUS) and the Copper T 380A.
Eligibility Criteria
Inclusion Criteria
Healthy, sexually active females age 14 to 18 who:
- Are interested in long term, reversible contraception
- Have regular menstrual cycles (21-35 days)
- Are not planning a pregnancy within the next 6 months
Exclusion Criteria
Sexually active females age over the age of 18 or who:
- Are not interested in long term, reversible contraception
- Do not have regular menstrual cycles (21-35 days)
- Are planning a pregnancy within the next 6 months
Data sourced from ClinicalTrials.gov (NCT00653159). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.