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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00520455
Enrollment
177
Registered
2007-08-24
Start date
2004-01-31
Completion date
2005-06-30
Last updated
2007-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

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.

Interventions

DRUGlevonorgestrel 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

Sponsors

Centers for Disease Control and Prevention
CollaboratorFED
University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Pregnancy1 year - measured via interview every 3 months

Secondary

MeasureTime frame
Abortion1 year - measured via interview every 3 months
Condom useMeasured every 3 months for one year
Use of hormonal contraceptionMeasured via interview every 3 months for one year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026