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OpenTrials
Completed

NCT Number: NCT00966771

The Copper T380A 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.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

Female

Study type

Observational

Primary location

Planned Parenthood Association of Utah Salt Lake City Clinic, Salt Lake City, Utah, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Copper T380 IUD

Drug

copper T 380 IUD

Other names: Paragard IUD

Oral levonorgestrel

Drug

1.5 mg

Other names: Plan B

Primary outcomes

  1. Unplanned pregnancy

    Time frame: within 12 months of presenting for EC

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Society of Family Planning

Registry information

Official study title

Preventing Future Pregnancy After Choosing the Copper IUD vs. Oral Levonorgestrel for Emergency Contraception

Acronym: IUD EC

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 27, 2009
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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