Semen ExposureNCT00984555
Residence Time of Biomarkers of Semen Exposure
An observational study of Semen Exposure, run by CONRAD at 2 sites in United States.
Trial summary
The purpose of this study is to examine the vaginal residence time of certain semen biomarkers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Semen Exposure
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2008to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community sample
Who may be able to join
- 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)
Who cannot join
- History of hysterectomy (females)
- History of vasectomy (males)
- Drug or alcohol abuse
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Eastern Virginia Medical School
Norfolk, Virginia, 23507
About this study
Official title: Assessment of the Vaginal Residence Time of Biomarkers of Semen Exposure
The purpose of this study is to examine the vaginal residence time of certain semen biomarkers.
Read the 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.
- Conditions
- Semen Exposure
- Keywords
- Biomarkers, Semen Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Levels of listed biomarkers in vaginal swabs taken
Measured: 6, 24, 48, 72 hours and 7, 11 and 15 days after vaginal inoculation with semen or unprotected intercourse
Secondary outcomes (1)
Percent of all women with a detectable level of each marker at each time point
Measured: 6, 24, 48, 72 hours, and 7, 11, and 15 days after vaginal inoculation with semen or unprotected intercourse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Semen ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CONRAD
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Eastern Virginia Medical School
- Investigators
- Roxanne Jamshidi, MD, MPH, Principal investigator, Johns Hopkins School of MedicineDavid F Archer, MD, Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984555
- Sponsor's protocol ID
- A07-105
- Status last verified
- Jul 2010
- First submitted
- 24 Sep 2009
- Last updated
- 22 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 27259675
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Vaginal Residence Time of Biomarkers of Semen Exposure
- ClinicalTrials.gov ID
- NCT00984555
- Acronym / sponsor ID
- A07-105
- Conditions
- Semen Exposure
- Keywords
- Biomarkers, Semen Exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- CONRADUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Eastern Virginia Medical School
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the vaginal residence time of certain semen biomarkers.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- History of hysterectomy (females)
- History of vasectomy (males)
- Drug or alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2010.
- Derived from this study: PubMed 27259675Thurman 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roxanne Jamshidi, MD, MPH principal investigator
Johns Hopkins School of Medicine
David F Archer, MD principal investigator
Eastern Virginia Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Semen Exposure, run by CONRAD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00984555, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2010.