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

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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

	Copper T380 IUD	Levonorgestrel
STARTED	23	34
COMPLETED	13	22
NOT COMPLETED	10	12
Lost to Follow-up	10	12

Baseline Characteristics

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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

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1. Primary:

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

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2. Secondary:

Pregnancy [ 6 months ]

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3. Secondary:

Infection [ 6 months ]

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Measure Type	Secondary
Measure Title	Infection
Measure Description	diagnosis and treatment for pelvic inflammatory disease
Time Frame	6 months
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Copper T380 IUD	IUD
Levonorgestrel	Oral levonorgestrel

Measured Values

	Copper T380 IUD	Levonorgestrel
Number of Participants Analyzed [units: participants]	13	22
Infection [units: participants]	0	0

No statistical analysis provided for Infection

4. Secondary:

IUD Expulsion, Removal, or Perforation [ 6 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: David Turok, MD
Organization: University of Utah
phone: 801-581-7647
e-mail: david.turok@hsc.utah.edu

No publications provided

Responsible Party:	Department of Obstetrics and Gynecology, University of Utah ( David Turok, MD/MPH )
Study ID Numbers:	23111, IUDvsPlanBforEC
Study First Received:	April 25, 2008
Results First Received:	June 18, 2009
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00669396 History of Changes
Health Authority:	United States: Food and Drug Administration