Clinical Trial on Semen Exposure - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Semen Exposure

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.

Study Type

Observational

Enrollment (Anticipated)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Maryland
  - Baltimore, Maryland, United States, 21224
    - Johns Hopkins Bayview Medical Center
- Virginia
  - Norfolk, Virginia, United States, 23507
    - Eastern Virginia Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	6, 24, 48, 72 hours and 7, 11 and 15 days after vaginal inoculation with semen or unprotected intercourse

Secondary Outcome Measures

Outcome Measure	Time Frame
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	6, 24, 48, 72 hours, and 7, 11, and 15 days after vaginal inoculation with semen or unprotected intercourse

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CONRAD

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Thurman A, Jacot T, Melendez J, Kimble T, Snead M, Jamshidi R, Wheeless A, Archer DF, Doncel GF, Mauck C. Assessment of the vaginal residence time of biomarkers of semen exposure. Contraception. 2016 Nov;94(5):512-520. doi: 10.1016/j.contraception.2016.05.012. Epub 2016 May 31.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

September 24, 2009

First Submitted That Met QC Criteria