Randomized Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia - Full Text View

Sponsors and Collaborators:	University of Washington Centers for Disease Control and Prevention
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00520455

Purpose

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.

Condition	Intervention
Pregnancy	Drug: levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms

MedlinePlus related topics: Birth Control Chlamydia Infections Gonorrhea

Drug Information available for: Levonorgestrel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Controlled Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia

Further study details as provided by University of Washington:

Primary Outcome Measures:

Pregnancy [ Time Frame: 1 year - measured via interview every 3 months ]

Secondary Outcome Measures:

Abortion [ Time Frame: 1 year - measured via interview every 3 months ]
Condom use [ Time Frame: Measured every 3 months for one year ]
Use of hormonal contraception [ Time Frame: Measured via interview every 3 months for one year ]

Enrollment:	177
Study Start Date:	January 2004
Study Completion Date:	June 2005

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

Eligibility

Ages Eligible for Study:	16 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520455

Locations

United States, Washington
Public Health - Seattle & King County STD Clinic
Seattle, Washington, United States, 98104

Sponsors and Collaborators

University of Washington

Centers for Disease Control and Prevention

Investigators

Principal Investigator:

Matthew R Golden, MD, MPH

University of Washington

More Information

Study ID Numbers:	037249C
Study First Received:	August 22, 2007
Last Updated:	November 13, 2007
ClinicalTrials.gov Identifier:	NCT00520455
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Levonorgestrel
Chlamydia Infections
Emergencies
Gonorrhea

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Contraceptive Agents
Therapeutic Uses
Contraceptives, Oral

Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009