Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception
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Tracking Information | |||||
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First Received Date ICMJE | April 25, 2008 | ||||
Last Updated Date | February 18, 2011 | ||||
Start Date ICMJE | April 2008 | ||||
Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception [ Time Frame: 6 months ] [ Designated as safety issue: No ] 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. |
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Original Primary Outcome Measures ICMJE |
Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
Change History | Complete list of historical versions of study NCT00669396 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception | ||||
Official Title ICMJE | A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel for Emergency Contraception | ||||
Brief Summary | The purpose of this study is to see if women presenting for emergency contraception (EC) are willing to accept the copper intrauterine device (IUD). This study will also compare the use of effective methods of contraception between women who selected the copper IUD or Plan B 6 months after they received EC. |
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Detailed Description | This study seeks to estimate the acceptance of Copper IUD use amongst people presenting for EC. This will be accomplished by offering all women who present for EC at participating Planned Parenthood Association of Utah (PPAU) clinics during the study period the option of having the copper IUD or Plan B. Women who agree to study participation will be followed for 6 months. The primary outcome for the study is the use of a reliable method of contraception 6 months after presenting for EC. Secondary outcomes measured will be pregnancies, abortions, repeat Plan B use, presence of gonorrhea or Chlamydia infection at the time of presentation for EC, number of days to first bleeding episode and duration of that bleeding episode, further bleeding patterns, frequency of unprotected intercourse, use of a barrier method for prevention of sexually transmitted infections, patient satisfaction with the chosen method and symptoms possibly related to contraception use. Patients selecting the IUD will be assessed for IUD expulsion, perforation, and removal. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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Condition ICMJE | Pregnancy | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 57 | ||||
Completion Date | May 2009 | ||||
Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years to 45 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00669396 | ||||
Other Study ID Numbers ICMJE | 23111, IUDvsPlanBforEC | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | David Turok, MD/MPH, Department of Obstetrics and Gynecology, University of Utah | ||||
Study Sponsor ICMJE | University of Utah | ||||
Collaborators ICMJE | Anonymous | ||||
Investigators ICMJE |
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Information Provided By | University of Utah | ||||
Verification Date | February 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |