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

NCT ID: NCT00520455

Last Updated: 2007-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-06-30

Brief Summary

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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

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Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

levonorgestrel 0.75mg taken twice 12 hours apart (Plan B). Study subjects to take medication after unprotected vaginal intercourse

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Plan B

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Principal Investigators

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Matthew R Golden, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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Public Health - Seattle & King County STD Clinic

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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037249C

Identifier Type: -

Identifier Source: org_study_id