Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception

This study has been completed.

Study NCT00669396 Information provided by University of Utah

First Received: April 25, 2008 Last Updated: August 11, 2009 History of Changes

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Active Control, Parallel Assignment
Condition:	Pregnancy
Interventions:	Drug: Copper T380 IUD Drug: levonorgestrel

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Copper T380 IUD	IUD
Levonorgestrel	Oral levonorgestrel

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
Copper T380 IUD	IUD
Levonorgestrel	Oral levonorgestrel

Baseline Measures

	Copper T380 IUD	Levonorgestrel	Total
Number of Participants [units: participants]	23	34	57
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	23	34	57
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	24.7 ± 6.7	23.0 ± 4.7	23.7 ± 5.6
Gender [units: participants]
Female	23	34	57
Male	0	0	0
Region of Enrollment [units: participants]
United States	23	34	57

Outcome Measures

1. Primary:

Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception [ 6 months ]

Show Outcome Measure 1

2. Secondary:

Pregnancy [ 6 months ]

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3. Secondary:

Infection [ 6 months ]

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4. Secondary:

IUD Expulsion, Removal, or Perforation [ 6 months ]

Show Outcome Measure 4