Phase 4 Completed N=23 Randomized Single-blind Treatment

Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial

Contraception

Source: ClinicalTrials.gov NCT00653159 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2012

Primary outcomePrimary: Retention Rate — 55; 75 percentage of randomized subjects — p=0.4003

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.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.