Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception

Phase

N/A

Condition

Pregnancy

Treatment

N/A

Clinical Study ID

NCT00669396

23111

IUDvsPlanBforEC

Ages 18-45
Female
Accepts Healthy Volunteers

Study Summary

The purpose of this study is to see if women presenting for emergency contraception (EC) are willing to accept the copper intrauterine device (IUD). This study will also compare the use of effective methods of contraception between women who selected the copper IUD or Plan B 6 months after they received EC.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Women 18-45 years old, in need of EC (had unprotected intercourse within 120 hours),willing to give consent for participation in research, willing to comply with thestudy requirements, and accessible by telephone.
Patients selecting the IUD need to identify themselves as desiring long-termcontraception.

Exclusion

Exclusion Criteria:

Current pregnancy,
Had pelvic inflammatory disease or a septic abortion within the past 3 months orgonorrheal or chlamydial infection in the last 60 days,
Current behavior suggesting a high risk for pelvic inflammatory disease
Allergy to copper, or Wilson's disease (for patients selecting Paragard) or allergy tolevonorgestrel (for patients selecting Plan B)
Intracavitary of symptomatic uterine fibroids, and abnormalities of the uterus thatdistort the uterine cavity,
Mucopurulent cervicitis,
A previously placed IUD that has not been removed
Genital bleeding of unknown etiology
Ovarian, cervical or endometrial cancer,
Small uterine cavity

Study Design

April 01, 2008

May 31, 2009

Study Description

This study seeks to estimate the acceptance of Copper IUD use amongst people presenting for EC. This will be accomplished by offering all women who present for EC at participating Planned Parenthood Association of Utah (PPAU) clinics during the study period the option of having the copper IUD or Plan B. Women who agree to study participation will be followed for 6 months. The primary outcome for the study is the use of a reliable method of contraception 6 months after presenting for EC.

Secondary outcomes measured will be pregnancies, abortions, repeat Plan B use, presence of gonorrhea or Chlamydia infection at the time of presentation for EC, number of days to first bleeding episode and duration of that bleeding episode, further bleeding patterns, frequency of unprotected intercourse, use of a barrier method for prevention of sexually transmitted infections, patient satisfaction with the chosen method and symptoms possibly related to contraception use. Patients selecting the IUD will be assessed for IUD expulsion, perforation, and removal.

Connect with a study center

Planned Parenthood Association of Utah, West Valley City Clinic
West Valley City, Utah 84119
United States
Site Not Available

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