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
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Drug: Copper T380 IUD Drug: levonorgestrel||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel for Emergency Contraception|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||May 2009|
Drug: Copper T380 IUD
Copper T380 IUD
Other Name: Paragard IUD
Active Comparator: 2
Other Name: Plan B
- Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception [ Time Frame: 6 months ]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.
- Pregnancy [ Time Frame: 6 months ]positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.
- Infection [ Time Frame: 6 months ]diagnosis and treatment for pelvic inflammatory disease
- IUD Expulsion, Removal, or Perforation [ Time Frame: 6 months ]patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669396
|United States, Utah|
|Planned Parenthood Association of Utah, West Valley City Clinic|
|West Valley City, Utah, United States, 84119|
|Principal Investigator:||David Turok, MD/MPH||University of Utah|