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Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B 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); levonorgestrel (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Utah

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


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.

Clinical Details

Official title: A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel for Emergency Contraception

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception

Secondary outcome:



IUD Expulsion, Removal, or Perforation

Detailed 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.


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.


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 the study requirements, and accessible by telephone.

- Patients selecting the IUD need to identify themselves as desiring long-term

contraception. Exclusion Criteria:

- Current pregnancy,

- Had pelvic inflammatory disease or a septic abortion within the past 3 months or

gonorrheal 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

to levonorgestrel (for patients selecting Plan B)

- Intracavitary of symptomatic uterine fibroids, and abnormalities of the uterus that

distort 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

Locations and Contacts

Planned Parenthood Association of Utah, West Valley City Clinic, West Valley City, Utah 84119, United States
Additional Information

Starting date: April 2008
Last updated: December 4, 2014

Page last updated: August 23, 2015

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