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The Copper T380A IUD vs. Oral Levonorgestrel for Emergency Contraception (IUD EC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00966771
First Posted: August 27, 2009
Last Update Posted: February 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Society of Family Planning
Information provided by (Responsible Party):
David Turok, University of Utah
August 25, 2009
August 27, 2009
February 6, 2017
October 2009
August 2011   (Final data collection date for primary outcome measure)
Unplanned pregnancy [ Time Frame: within 12 months of presenting for EC ]
Same as current
Complete list of historical versions of study NCT00966771 on ClinicalTrials.gov Archive Site
  • Use of an effective method of contraception in the year following use of emergency contraception. [ Time Frame: 12 months ]
  • IUD expulsion, removal or perforation [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
 
The Copper T380A IUD vs. Oral Levonorgestrel for Emergency Contraception
Preventing Future Pregnancy After Choosing the Copper IUD vs. Oral Levonorgestrel for Emergency Contraception
The purpose of this study is to see if women presenting for emergency contraception (EC) and choose the copper intrauterine device (IUD) will have fewer unplanned pregnancies in the next year compared to women who choose oral levonorgestrel for EC. The study will also compare use of an effective method of contraception in the year after they received EC.

All women presenting to 2 Planned Parenthood Association of Utah clinics in Salt Lake City will be offered participation in this study. Women will select either the copper IUD or oral levonorgestrel for EC. The primary outcome is unplanned pregnancy in the year following presentation for EC.

Secondary outcomes include use of an effective method of contraception over the next year, abortions, repeat use of EC, number of days to first bleeding episode and duration of that bleeding episode, use of a barrier method to prevent sexually transmitted infections, patient satisfaction with the chosen method of EC and contraception. Participants selecting the IUD will be assessed for IUD expulsion, perforation, and removal.

Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Women presenting to family planning clinics for emergency contraception
Pregnancy
  • Drug: Copper T380 IUD
    copper T 380 IUD
    Other Name: Paragard IUD
  • Drug: Oral levonorgestrel
    1.5 mg
    Other Name: Plan B
  • IUD
    Women presenting for emergency contraception who select the copper IUD
    Intervention: Drug: Copper T380 IUD
  • Oral levonorgestrel
    Women presenting for emergency contraception who select oral levonorgestrel
    Intervention: Drug: Oral levonorgestrel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
548
August 2011
August 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women 18-30 years old,
  • in need of emergency contraception (had unprotected intercourse within 120 hours),
  • willing to give consent for participation in research,
  • willing to comply with study requirements, and
  • accessible by telephone.

Participants selecting the IUD need to identify themselves as desiring long-term contraception.

Exclusion Criteria:

  • Current pregnancy
  • Had pelvic inflammatory disease or septic abortion within the past 3 months or had gonorrhea or chlamydia infection in the last 60 days
  • Current behavior suggesting a high risk for pelvic inflammatory disease
  • Allergy to copper or Wilson's disease (for participants selecting the copper IUD) or allergy to levonorgestrel (for participants selecting oral levonorgestrel)
  • Abnormalities of the uterus that distort the uterine cavity
  • Mucopurulent cervicitis
  • A previously placed IUD that has not been removed
  • Genital bleeding of an unknown etiology
  • Ovarian, cervical, or endometrial cancer
  • Small uterine cavity (< 6cm)
Sexes Eligible for Study: Female
18 Years to 30 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00966771
30937
1R21HD063028-01A1 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: No
David Turok, University of Utah
University of Utah
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Society of Family Planning
Principal Investigator: David Turok, MD University of Utah
University of Utah
October 2016