Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Non-Invasive Sexually Transmitted Disease (STD) Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing: Meeting the Needs of an At-Risk Population

This study has been completed.
Sponsor:
Collaborator:
Gen-Probe, Incorporated
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00978848
First received: September 16, 2009
Last updated: July 8, 2010
Last verified: July 2010

September 16, 2009
July 8, 2010
November 2009
April 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00978848 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Non-Invasive Sexually Transmitted Disease (STD) Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing: Meeting the Needs of an At-Risk Population
Non-Invasive STD Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing: Meeting the Needs of an At-Risk Population

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

Any left over urine may be frozen for future use on infections in women

Non-Probability Sample

Females at least age 15 at time of enrollment who are presenting at Magee-Womens Hospital for emergency contraception or urine pregnancy testing

  • Trichomonas Vaginalis Infection
  • Chlamydia Trachomatis
  • Neisseria Gonorrhoeae
Not Provided
  • women seeking emergency contraception
  • Women seeking urine pregnancy testing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
305
April 2010
April 2010   (final data collection date for primary outcome measure)

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.
Female
15 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00978848
PRO8120077
No
Harold C. Wiesenfeld, MD, CM, University of Pittsburgh
University of Pittsburgh
Gen-Probe, Incorporated
Principal Investigator: Harold C Wiesenfeld, MD, CM University of Pittsburgh
University of Pittsburgh
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP