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Trial record 55 of 404 for:    LEVONORGESTREL

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

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ClinicalTrials.gov Identifier: NCT00669396
Recruitment Status : Completed
First Posted : April 30, 2008
Results First Posted : August 6, 2009
Last Update Posted : December 22, 2014
Sponsor:
Information provided by (Responsible Party):
David Turok, University of Utah

Tracking Information
First Submitted Date  ICMJE April 25, 2008
First Posted Date  ICMJE April 30, 2008
Results First Submitted Date  ICMJE June 18, 2009
Results First Posted Date  ICMJE August 6, 2009
Last Update Posted Date December 22, 2014
Study Start Date  ICMJE April 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2008)
Use of an Effective Method of Contraception at 6 Months After Requesting Emergency Contraception [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT00669396 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2011)
  • Pregnancy [ Time Frame: 6 months ]
    positive urine pregnancy test at anytime within 6 months of presenting for emergency contraception.
  • Infection [ Time Frame: 6 months ]
    diagnosis and treatment for pelvic inflammatory disease
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2008)
  • Pregnancy [ Time Frame: 6 months ]
  • Infection [ Time Frame: 6 months ]
  • Bleeding patterns [ Time Frame: 6 months ]
  • IUD Expulsion, Removal, or Perforation [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Copper T380 IUD Versus Oral Levonorgestrel for Emergency Contraception vs. Plan B for Emergency Contraception
Official Title  ICMJE A Pilot Study of Copper T380A IUDs Versus Oral Levonorgestrel for Emergency Contraception
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pregnancy
Intervention  ICMJE
  • Drug: Copper T380 IUD
    Copper T380 IUD
    Other Name: Paragard IUD
  • Drug: levonorgestrel
    1.5 mg
    Other Name: Plan B
Study Arms  ICMJE
  • Experimental: 1
    IUD
    Intervention: Drug: Copper T380 IUD
  • Active Comparator: 2
    Oral levonorgestrel
    Intervention: Drug: levonorgestrel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 4, 2009)
57
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2008)
268
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00669396
Other Study ID Numbers  ICMJE 23111
IUDvsPlanBforEC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Turok, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Turok, MD/MPH University of Utah
PRS Account University of Utah
Verification Date December 2014

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