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NCT00520455 Clinical Trial

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

Pregnancy Clinical Trial

Official title:
Randomized Controlled Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00520455
Other study ID # 037249C
Secondary ID
Status Completed
Phase N/A
First received August 22, 2007
Last updated November 13, 2007
Start date January 2004
Est. completion date June 2005

Study information
Verified date November 2007
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 177
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 16 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Public Health - Seattle & King County STD Clinic Seattle Washington

Sponsors (2)
Lead Sponsor Collaborator
University of Washington Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pregnancy 1 year - measured via interview every 3 months
Secondary Abortion 1 year - measured via interview every 3 months
Secondary Condom use Measured every 3 months for one year
Secondary Use of hormonal contraception Measured via interview every 3 months for one year
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