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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00520455
First Posted: August 24, 2007
Last Update Posted: November 15, 2007
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.
Collaborator:
Centers for Disease Control and Prevention
Information provided by:
University of Washington
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

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.


Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00520455     History of Changes
Other Study ID Numbers: 037249C
First Submitted: August 22, 2007
First Posted: August 24, 2007
Last Update Posted: November 15, 2007
Last Verified: November 2007

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
Contraceptives, Oral, Synthetic
Contraceptives, Oral