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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00669396
Recruitment Status : Completed
First Posted : April 30, 2008
Results First Posted : August 6, 2009
Last Update Posted : December 22, 2014
Information provided by (Responsible Party):
David Turok, University of Utah

Brief 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.

Condition or disease Intervention/treatment Phase
Pregnancy Drug: Copper T380 IUD Drug: levonorgestrel Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel for Emergency Contraception
Study Start Date : April 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: 1
Drug: Copper T380 IUD
Copper T380 IUD
Other Name: Paragard IUD

Active Comparator: 2
Oral levonorgestrel
Drug: levonorgestrel
1.5 mg
Other Name: Plan B

Primary Outcome Measures :
  1. Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception [ Time Frame: 6 months ]
    Use of a method of contraception with a typical efficacy rate >= to 92%. This includes combined hormonal contraception (combined oral contraceptive pills, the contraceptive patch and ring), sterilization, IUDs, Depo-provera, and contraceptive implants.

Secondary Outcome Measures :
  1. Pregnancy [ Time Frame: 6 months ]
    positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.

  2. Infection [ Time Frame: 6 months ]
    diagnosis and treatment for pelvic inflammatory disease

  3. IUD Expulsion, Removal, or Perforation [ Time Frame: 6 months ]
    patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00669396

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United States, Utah
Planned Parenthood Association of Utah, West Valley City Clinic
West Valley City, Utah, United States, 84119
Sponsors and Collaborators
University of Utah
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Principal Investigator: David Turok, MD/MPH University of Utah
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Responsible Party: David Turok, PI, University of Utah Identifier: NCT00669396    
Other Study ID Numbers: 23111
First Posted: April 30, 2008    Key Record Dates
Results First Posted: August 6, 2009
Last Update Posted: December 22, 2014
Last Verified: December 2014
Keywords provided by David Turok, University of Utah:
emergency contraception
pregnancy prevention after unprotected intercourse
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Trace Elements
Growth Substances