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The Copper T380A IUD vs. Oral Levonorgestrel for Emergency Contraception

Information source: University of Utah
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pregnancy

Intervention: Copper T380 IUD (Drug); Oral levonorgestrel (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: University of Utah

Official(s) and/or principal investigator(s):
David Turok, MD, Principal Investigator, Affiliation: University of Utah

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.

Clinical Details

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

Study design: Time Perspective: Prospective

Primary outcome: Unplanned pregnancy

Secondary outcome:

Use of an effective method of contraception in the year following use of emergency contraception.

IUD expulsion, removal or perforation

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

Minimum age: 18 Years. Maximum age: 30 Years. Gender(s): Female.

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)

Locations and Contacts

Planned Parenthood Association of Utah Salt Lake City Clinic, Salt Lake City, Utah 84102-3430, United States

Planned Parenthood Association of Utah, West Valley City Clinic, West Valley City, Utah 84119-4715, United States

Additional Information

Starting date: October 2009
Last updated: December 15, 2011

Page last updated: August 23, 2015

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