Back to resultsRandomized Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia
Primary Purpose
Pregnancy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy
Eligibility 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.
Sites / Locations
- Public Health - Seattle & King County STD Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Pregnancy
Secondary Outcome Measures
Abortion
Condom use
Use of hormonal contraception
Full Information
NCT ID
NCT00520455
First Posted
August 22, 2007
Last Updated
November 13, 2007
Sponsor
University of Washington
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT00520455
Brief Title
Randomized Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia
Official Title
Randomized Controlled Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Washington
Collaborators
Centers for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
177 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms
Other Intervention Name(s)
Plan B
Intervention Description
levonorgestrel 0.75mg taken twice 12 hours apart (Plan B). Study subjects to take medication after unprotected vaginal intercourse
Primary Outcome Measure Information:
Title
Pregnancy
Time Frame
1 year - measured via interview every 3 months
Secondary Outcome Measure Information:
Title
Abortion
Time Frame
1 year - measured via interview every 3 months
Title
Condom use
Time Frame
Measured every 3 months for one year
Title
Use of hormonal contraception
Time Frame
Measured via interview every 3 months for one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew R Golden, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Public Health - Seattle & King County STD Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Randomized Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia
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