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

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ClinicalTrials.gov Identifier: NCT00966771
Recruitment Status : Completed
First Posted : August 27, 2009
Last Update Posted : February 6, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Pregnancy Drug: Copper T380 IUD Drug: Oral levonorgestrel

Detailed Description:

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.


Study Design

Study Type : Observational
Actual Enrollment : 548 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Preventing Future Pregnancy After Choosing the Copper IUD vs. Oral Levonorgestrel for Emergency Contraception
Study Start Date : October 2009
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
IUD
Women presenting for emergency contraception who select the copper IUD
Drug: Copper T380 IUD
copper T 380 IUD
Other Name: Paragard IUD
Oral levonorgestrel
Women presenting for emergency contraception who select oral levonorgestrel
Drug: Oral levonorgestrel
1.5 mg
Other Name: Plan B


Outcome Measures

Primary Outcome Measures :
  1. Unplanned pregnancy [ Time Frame: within 12 months of presenting for EC ]

Secondary Outcome Measures :
  1. Use of an effective method of contraception in the year following use of emergency contraception. [ Time Frame: 12 months ]
  2. IUD expulsion, removal or perforation [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women presenting to family planning clinics for emergency contraception
Criteria

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)
Contacts and Locations

Information from the National Library of Medicine

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): NCT00966771


Locations
United States, Utah
Planned Parenthood Association of Utah Salt Lake City Clinic
Salt Lake City, Utah, United States, 84102-3430
Planned Parenthood Association of Utah, West Valley City Clinic
West Valley City, Utah, United States, 84119-4715
Sponsors and Collaborators
University of Utah
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Society of Family Planning
Investigators
Principal Investigator: David Turok, MD University of Utah
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Turok, Clinical Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT00966771     History of Changes
Other Study ID Numbers: 30937
1R21HD063028-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 27, 2009    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by David Turok, University of Utah:
contraception
emergency contraception
pregnancy prevention after unprotected intercourse

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Levonorgestrel
Copper
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Trace Elements
Micronutrients
Growth Substances