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

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ClinicalTrials.gov Identifier: NCT00520455
Recruitment Status : Completed
First Posted : August 24, 2007
Last Update Posted : November 15, 2007
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by:
University of Washington

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.

Condition or disease Intervention/treatment Phase
Pregnancy Drug: levonorgestrel 0.75mg taken twice 12 hours apart (Plan B) and condoms Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Advanced Provision Emergency Contraception Among Women With Gonorrhea or Chlamydia
Study Start Date : January 2004
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 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.
Experimental: 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
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
Other Name: Plan B



Primary Outcome Measures :
  1. Pregnancy [ Time Frame: 1 year - measured via interview every 3 months ]

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


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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00520455     History of Changes
Other Study ID Numbers: 037249C
First Posted: August 24, 2007    Key Record Dates
Last Update Posted: November 15, 2007
Last Verified: November 2007

Additional relevant MeSH terms:
Emergencies
Gonorrhea
Disease Attributes
Pathologic Processes
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral