Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Non-Invasive Sexually Transmitted Disease Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00978848
Recruitment Status : Completed
First Posted : September 17, 2009
Last Update Posted : May 18, 2016
Sponsor:
Collaborator:
Gen-Probe, Incorporated
Information provided by (Responsible Party):
Harold Wiesenfeld, University of Pittsburgh

Tracking Information
First Submitted Date September 16, 2009
First Posted Date September 17, 2009
Last Update Posted Date May 18, 2016
Study Start Date November 2009
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-Invasive Sexually Transmitted Disease Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing
Official Title Non-Invasive Sexually Transmitted Disease Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing: Meeting the Needs of an At-Risk Population
Brief Summary The purpose of this study is to determine the prevalence and treatment rates of T. vaginalis, C. trachomatis, and N. gonorrhoeae in women seeking emergency contraception or urine pregnancy testing in the Magee-Womens Hospital outpatient clinic using a non-invasive urine STD test.
Detailed Description This study has three primary objectives: 1) to determine the prevalence of T. vaginalis, C. trachomatis, and N. gonorrhoeae in women seeking emergency contraception or urine pregnancy testing - a population likely at increased risk of acquiring STDs; 2) to determine the rate of successful treatment in women diagnosed with STDs in this venue.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Any left over urine may be frozen for future use on infections in women
Sampling Method Non-Probability Sample
Study Population Females at least age 15 at time of enrollment who are presenting at Magee-Womens Hospital for emergency contraception or urine pregnancy testing
Condition
  • Trichomonas Vaginitis
  • Chlamydia Trachomatis
  • Neisseria Gonorrhoeae Infection
Intervention Not Provided
Study Groups/Cohorts
  • Women seeking emergency contraception
    Women seeking emergency contraception
  • Women seeking urine pregnancy testing
    Women seeking urine pregnancy testing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 8, 2010)
305
Original Estimated Enrollment
 (submitted: September 16, 2009)
330
Actual Study Completion Date April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Females at least age 15 at time of enrollment who are presenting at Magee-Womens Hospital for emergency contraception or urine pregnancy testing.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Diagnosis and/or treatment for an STD within 4 weeks of enrollment in the study.
Sex/Gender
Sexes Eligible for Study: Female
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00978848
Other Study ID Numbers PRO8120077
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Harold Wiesenfeld, University of Pittsburgh
Study Sponsor University of Pittsburgh
Collaborators Gen-Probe, Incorporated
Investigators
Principal Investigator: Harold C Wiesenfeld, MD, CM University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date May 2016