The Copper T380A IUD vs. Oral Levonorgestrel for Emergency Contraception

Pregnancy Clinical Trial

— IUD EC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966771
• Other study ID #: 30937
• Secondary ID: 1R21HD063028-01A
• Status: Completed
• Phase: N/A
• First received: August 25, 2009
• Last updated: February 2, 2017
• Start date: October 2009
• Est. completion date: August 2011

Study information

• Verified date: October 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 548
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Emergencies
• Pregnancy

Intervention

Drug:
• Copper T380 IUD
copper T 380 IUD
• Oral levonorgestrel
1.5 mg

Locations

Country	Name	City	State
United States	Planned Parenthood Association of Utah Salt Lake City Clinic	Salt Lake City	Utah
United States	Planned Parenthood Association of Utah, West Valley City Clinic	West Valley City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unplanned pregnancy		within 12 months of presenting for EC
Secondary	Use of an effective method of contraception in the year following use of emergency contraception.		12 months
Secondary	IUD expulsion, removal or perforation		12 months