Residence Time of Biomarkers of Semen Exposure
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 24, 2009 | ||||||||
| Last Updated Date | July 21, 2010 | ||||||||
| Start Date ICMJE | December 2008 | ||||||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00984555 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Residence Time of Biomarkers of Semen Exposure | ||||||||
| Official Title ICMJE | Assessment of the Vaginal Residence Time of Biomarkers of Semen Exposure | ||||||||
| Brief Summary | The purpose of this study is to examine the vaginal residence time of certain semen biomarkers. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Vaginal swabs, semen |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Community sample |
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| Condition ICMJE | Semen Exposure | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 64 | ||||||||
| Completion Date | July 2010 | ||||||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 55 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00984555 | ||||||||
| Other Study ID Numbers ICMJE | A07-105 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Jill Schwartz, Medical Director, CONRAD | ||||||||
| Study Sponsor ICMJE | CONRAD | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | CONRAD | ||||||||
| Verification Date | July 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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