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

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ClinicalTrials.gov Identifier: NCT00669396
Recruitment Status : Completed
First Posted : April 30, 2008
Results First Posted : August 6, 2009
Last Update Posted : December 22, 2014
Sponsor:
Information provided by (Responsible Party):
David Turok, University of Utah

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Pregnancy
Interventions Drug: Copper T380 IUD
Drug: levonorgestrel
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Copper T380 IUD Levonorgestrel
Hide Arm/Group Description IUD Oral levonorgestrel
Period Title: Overall Study
Started 23 34
Completed 13 22
Not Completed 10 12
Reason Not Completed
Lost to Follow-up             10             12
Arm/Group Title Copper T380 IUD Levonorgestrel Total
Hide Arm/Group Description IUD Oral levonorgestrel Total of all reporting groups
Overall Number of Baseline Participants 23 34 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 34 participants 57 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
 100.0%
34
 100.0%
57
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 34 participants 57 participants
24.7  (6.7) 23.0  (4.7) 23.7  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 34 participants 57 participants
Female
23
 100.0%
34
 100.0%
57
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 34 participants 57 participants
23 34 57
1.Primary Outcome
Title Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception
Hide Description Use of a method of contraception with a typical efficacy rate >= to 92%. This includes combined hormonal contraception (combined oral contraceptive pills, the contraceptive patch and ring), sterilization, IUDs, Depo-provera, and contraceptive implants.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Copper T380 IUD Levonorgestrel
Hide Arm/Group Description:
IUD
Oral levonorgestrel
Overall Number of Participants Analyzed 13 22
Measure Type: Number
Unit of Measure: participants
9 13
2.Secondary Outcome
Title Pregnancy
Hide Description positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Copper T380 IUD Levonorgestrel
Hide Arm/Group Description:
IUD
Oral levonorgestrel
Overall Number of Participants Analyzed 13 22
Measure Type: Number
Unit of Measure: participants
0 2
3.Secondary Outcome
Title Infection
Hide Description diagnosis and treatment for pelvic inflammatory disease
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Copper T380 IUD Levonorgestrel
Hide Arm/Group Description:
IUD
Oral levonorgestrel
Overall Number of Participants Analyzed 13 22
Measure Type: Number
Unit of Measure: participants
0 0
4.Secondary Outcome
Title IUD Expulsion, Removal, or Perforation
Hide Description patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Copper T380 IUD Levonorgestrel
Hide Arm/Group Description:
IUD
Oral levonorgestrel
Overall Number of Participants Analyzed 13 22
Measure Type: Number
Unit of Measure: participants
5 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Copper T380 IUD Levonorgestrel
Hide Arm/Group Description IUD Oral levonorgestrel
All-Cause Mortality
Copper T380 IUD Levonorgestrel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Copper T380 IUD Levonorgestrel
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/34 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Copper T380 IUD Levonorgestrel
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/34 (0.00%) 
[Not Specified]
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Turok, MD
Organization: University of Utah
Phone: 801-581-7647
EMail: david.turok@hsc.utah.edu
Layout table for additonal information
Responsible Party: David Turok, University of Utah
ClinicalTrials.gov Identifier: NCT00669396     History of Changes
Other Study ID Numbers: 23111
IUDvsPlanBforEC
First Submitted: April 25, 2008
First Posted: April 30, 2008
Results First Submitted: June 18, 2009
Results First Posted: August 6, 2009
Last Update Posted: December 22, 2014