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

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Drug: levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms

• Registration Number: NCT00520455
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study Completion: 2005-06
• Study First Submitted: 2007-08-22
• Study First Submitted QC: 2007-08-22
• Study First Posted: 2007-08-24
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-13
• Last Update Posted: 2007-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 177

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms	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

Primary Outcome Measures

Name	Time	Method
Pregnancy	1 year - measured via interview every 3 months

Secondary Outcome Measures

Name	Time	Method
Abortion	1 year - measured via interview every 3 months
Condom use	Measured every 3 months for one year
Use of hormonal contraception	Measured via interview every 3 months for one year

Trial Locations

Locations (1)

Public Health - Seattle & King County STD Clinic; 🇺🇸 Seattle, Washington, United States