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Randomized Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia

This study has been completed.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00520455
First received: August 22, 2007
Last updated: November 13, 2007
Last verified: November 2007
History of Changes

August 22, 2007
November 13, 2007
January 2004
Not Provided
Pregnancy [ Time Frame: 1 year - measured via interview every 3 months ]
Same as current
Complete list of historical versions of study NCT00520455 on ClinicalTrials.gov Archive Site
  • Abortion [ Time Frame: 1 year - measured via interview every 3 months ]
  • Condom use [ Time Frame: Measured every 3 months for one year ]
  • Use of hormonal contraception [ Time Frame: Measured via interview every 3 months for one year ]
Same as current
Not Provided
Not Provided
 
Randomized Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia
Randomized Controlled Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia

The purpose of this trial is to determine whether providing non-contracepting women with gonorrhea or chlamydial infection with advanced provision emergency contraception (APEC) and condoms decreases their risk of becoming pregnant.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Pregnancy
Drug: levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms
levonorgestrel 0.75mg taken twice 12 hours apart (Plan B). Study subjects to take medication after unprotected vaginal intercourse
Other Name: Plan B
  • No Intervention: Control
    Control participants were advised where they could obtain hormonal contraception on a sliding scale basis. Participants were also advised where they could obtain hormonal contraception on a sliding scale basis.
  • Experimental: Intervention
    Study subjects were prescribed levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and a package of 30 condoms provided via a commerical pharmacy at no cost to the study subject. The subject could refill this prescription as many times as they wanted for 12 months
    Intervention: Drug: levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
177
June 2005
Not Provided

Inclusion Criteria:

Non-contracepting women >15 years of age who were reported to Public Health Seattle & King County with a diagnosis for gonorrhea or chlamydial infection and who were interviewed by public health staff for purposes of partner notification

Exclusion Criteria:

  • Use of effective contraception (hormonal contraception, IUD, diaphragm); sex with only one partner in the preceding 60 days who was status post vasectomy; age <15; inability to speak English; history of tubal ligation, hysterectomy, or menopause.
Female
16 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00520455
037249C
No
Not Provided
University of Washington
Centers for Disease Control and Prevention
Principal Investigator: Matthew R Golden, MD, MPH University of Washington
University of Washington
November 2007

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