Residence Time of Biomarkers of Semen Exposure

This study has been completed.
Sponsor:
Collaborators:
Johns Hopkins University
Eastern Virginia Medical School
Information provided by:
CONRAD
ClinicalTrials.gov Identifier:
NCT00984555
First received: September 24, 2009
Last updated: July 21, 2010
Last verified: July 2010
  Purpose

The purpose of this study is to examine the vaginal residence time of certain semen biomarkers.


Condition
Semen Exposure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessment of the Vaginal Residence Time of Biomarkers of Semen Exposure

Further study details as provided by CONRAD:

Primary Outcome Measures:
  • Levels of listed biomarkers in vaginal swabs taken [ Time Frame: 6, 24, 48, 72 hours and 7, 11 and 15 days after vaginal inoculation with semen or unprotected intercourse ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of all women with a detectable level of each marker at each time point [ Time Frame: 6, 24, 48, 72 hours, and 7, 11, and 15 days after vaginal inoculation with semen or unprotected intercourse ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Vaginal swabs, semen


Estimated Enrollment: 64
Study Start Date: December 2008
Study Completion Date: July 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
A1 (Inoculation with 7 timepoints)
Semen exposure via inoculation, Vaginal swabs at 7 time points
A2 (Inoculation with 4 timepoints)
Semen exposure via inoculation, Vaginal swabs at 4 time points
B1 (intercourse with 7 timepoints)
Semen exposure via unprotected intercourse, Vaginal swabs at 7 time points
B2 (Intercourse with 4 timepoints)
Semen exposure via unprotected intercourse, Vaginal swabs at 4 time points

Detailed Description:

The study will take approximately 2-3 months to complete. First, you will be screened to see if you are eligible for the study. At this visit the male partner will give a medical history and be asked to donate a semen sample for analysis, while the female will give a medical history, receive a physical exam, pelvic exam, pregnancy test, and will be tested for vaginal infection including Gonorrhea/Chlamydia. If you are eligible (as a couple), you will be called and randomized into one of four study groups. You will be allowed to choose whether you want to take certain samples yourself at home, or have them all taken by a nurse at the clinic. At this point you will either be asked to return home to have sexual intercourse, or the male partner will be asked to donate a semen sample, which will then be inserted into the female's vagina. Depending on which group you are in, you will next be asked to return to the clinic either 4 or 7 times over the next 2 weeks for vaginal swabs.

Once you complete the main study, you will be offered the opportunity to participate in a substudy, where you will repeat the same visits, except that if you chose to have all your samples taken in the clinic for the main study, you will take certain samples at home for the substudy. If you chose to take certain samples at home for the main study, you will have all the samples taken at the clinic for the substudy. Also, you will not need to do another screening visit if you start the substudy within 9 weeks of the end of the main study.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Community sample

Criteria

Inclusion Criteria:

  • Heterosexual, monogamous couples
  • Must not be using birth control other than a tubal ligation
  • Must be at least 18 years old, and healthy (if female)
  • Must be between 18-55 years old, and healthy (if male)

Exclusion Criteria:

  • History of hysterectomy (females)
  • History of vasectomy (males)
  • Drug or alcohol abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984555

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
United States, Virginia
Eastern Virginia Medical School
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
CONRAD
Johns Hopkins University
Eastern Virginia Medical School
Investigators
Principal Investigator: Roxanne Jamshidi, MD, MPH Johns Hopkins School of Medicine
Principal Investigator: David F Archer, MD Eastern Virginia Medical School
  More Information

No publications provided

Responsible Party: Jill Schwartz, Medical Director, CONRAD
ClinicalTrials.gov Identifier: NCT00984555     History of Changes
Other Study ID Numbers: A07-105
Study First Received: September 24, 2009
Last Updated: July 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by CONRAD:
Biomarkers
Semen Exposure

ClinicalTrials.gov processed this record on August 20, 2014