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

NCT00520455 | Completed

• 1 other identifier: 037249C
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Pregnancy

  1 year - measured via interview every 3 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Interventions

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

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

Also known as: Plan B

Intervention

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Public Health - Seattle & King County STD Clinic

Seattle, Washington, 98104, United States

Location

MeSH Terms

Interventions

Levonorgestrel; Condoms

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Contraceptive Devices, Male; Contraceptive Devices; Equipment and Supplies

Study Officials

• Matthew R Golden, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 22, 2007
• First Posted: August 24, 2007
• Study Start: January 1, 2004
• Study Completion: June 1, 2005
• Last Updated: November 15, 2007

Record last verified: 2007-11

Locations

US (1)