Status:
WITHDRAWN
Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women
Lead Sponsor:
University of Pittsburgh
Conditions:
Bacterial Vaginosis
Herpes Simplex Virus Type II
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
We will be examining the effects of suppressive valacyclovir therapy on the stability of vaginal flora in women who are seropositive for HSV-2. We have preliminary data that suggests the presence of H...
Eligibility Criteria
Inclusion
- Screening
- Women 18-40 years of age at the time of screening
- Willing to be screened for HSV-2 using a rapid, FDA approved test
- Using an effective method of birth control (examples of effective methods of birth control are: women practicing abstinence x 90 days, hormonal birth control, consistent condom use, bilateral tubal ligation, partner with a vasectomy)
- Screening
Exclusion
- Pregnant or nursing mother
- Use of any antimicrobial agents (vaginal or systemic) for the treatment of any condition within 7 days
- Presence of any intrauterine device
- Allergy or hypersensitivity to valcyclovir or nucleoside analogues
- Enrollment Inclusion Criteria:
- Women 18-40 Years of age at the time of screening
- HSV-2 seropositive as determined by rapid HSV-2 testing
- Using an effective method of birth control (examples of effective methods of birth control are: women practicing abstinence x 90 days, hormonal birth control, consistent condom use, bilateral tubal ligation, partner with a vasectomy)
- Willing to avoid use of any intravaginal products during study period
- Capable of providing written informed consent
- Capable of cooperating to the extent and degree required by this protocol
- Enrollment
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00682721
Start Date
February 1 2009
End Date
September 1 2010
Last Update
March 2 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213