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

November 13, 2007 updated by: University of Washington

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

177

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • Public Health - Seattle & King County STD Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Plan B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pregnancy
Time Frame: 1 year - measured via interview every 3 months
1 year - measured via interview every 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Abortion
Time Frame: 1 year - measured via interview every 3 months
1 year - measured via interview every 3 months
Condom use
Time Frame: Measured every 3 months for one year
Measured every 3 months for one year
Use of hormonal contraception
Time Frame: Measured via interview every 3 months for one year
Measured via interview every 3 months for one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Matthew R Golden, MD, MPH, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

August 22, 2007

First Submitted That Met QC Criteria

August 22, 2007

First Posted (Estimate)

August 24, 2007

Study Record Updates

Last Update Posted (Estimate)

November 15, 2007

Last Update Submitted That Met QC Criteria

November 13, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 037249C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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