Status:
COMPLETED
The Copper T380A IUD vs. Oral Levonorgestrel for Emergency Contraception
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Society of Family Planning
Conditions:
Pregnancy
Eligibility:
FEMALE
18-30 years
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...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
548 Patients enrolled
Trial Details
Trial ID
NCT00966771
Start Date
October 1 2009
End Date
August 1 2011
Last Update
February 6 2017
Active Locations (2)
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1
Planned Parenthood Association of Utah Salt Lake City Clinic
Salt Lake City, Utah, United States, 84102-3430
2
Planned Parenthood Association of Utah, West Valley City Clinic
West Valley City, Utah, United States, 84119-4715