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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
  Purpose

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.


Condition Intervention
Pregnancy
 Drug: levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Pregnancy [ Time Frame: 1 year - measured via interview every 3 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 177
Study Start Date: January 2004
Study Completion Date: June 2005
Arms Assigned Interventions
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
 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

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520455

Locations
United States, Washington
Public Health - Seattle & King County STD Clinic
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Matthew R Golden, MD, MPH University of Washington
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00520455     History of Changes
Other Study ID Numbers: 037249C
Study First Received: August 22, 2007
Last Updated: November 13, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Emergencies
Gonorrhea
Disease Attributes
Pathologic Processes
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
 Genital Diseases, Female
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on May 23, 2013