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

This study is ongoing, but not recruiting participants.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00966771
First received: August 25, 2009
Last updated: December 15, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention
Pregnancy
 Drug: Copper T380 IUD
Drug: Oral levonorgestrel

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Preventing Future Pregnancy After Choosing the Copper IUD vs. Oral Levonorgestrel for Emergency Contraception

Resource links provided by NLM:

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

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Unplanned pregnancy [ Time Frame: within 12 months of presenting for EC ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Use of an effective method of contraception in the year following use of emergency contraception. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • IUD expulsion, removal or perforation [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 549
Study Start Date: October 2009
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: David Turok, Clinical Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT00966771     History of Changes
Other Study ID Numbers: 30937, 1R21HD063028-01A1
Study First Received: August 25, 2009
Last Updated: December 15, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 21, 2013