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

This study has been completed.
Sponsor:
Collaborator:
Anonymous
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00669396
First received: April 25, 2008
Last updated: February 18, 2011
Last verified: February 2011

April 25, 2008
February 18, 2011
April 2008
April 2009   (final data collection date for primary outcome measure)
Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00669396 on ClinicalTrials.gov Archive Site
  • Pregnancy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.
  • Infection [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    diagnosis and treatment for pelvic inflammatory disease
  • IUD Expulsion, Removal, or Perforation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    patient reports IUD expulsion, removal, or perforation OR one of these events was documented at the clinic where patient received care.
  • pregnancy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Bleeding patterns [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • IUD expulsion, removal, or perforation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
 
 
 
Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception
A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel for Emergency Contraception

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.

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.

Interventional
 
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Pregnancy
  • Drug: Copper T380 IUD
    Copper T380 IUD
    Other Name: Paragard IUD
  • Drug: levonorgestrel
    1.5 mg
    Other Name: Plan B
  • Experimental: 1
    IUD
    Intervention: Drug: Copper T380 IUD
  • Active Comparator: 2
    Oral levonorgestrel
    Intervention: Drug: levonorgestrel
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
May 2009
April 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00669396
23111, IUDvsPlanBforEC
Yes
David Turok, MD/MPH, Department of Obstetrics and Gynecology, University of Utah
University of Utah
Anonymous
Principal Investigator: David Turok, MD/MPH University of Utah
University of Utah
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP