Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006207
Status:
COMPLETED
Last Update Posted:
2008-07-30
First Post:
2000-09-11
Brief Title:
Safety and Tolerability of the Vaginal Gel PRO 20005
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Multicenter Dose Escalation Safety and Acceptability Study of the Investigational Vaginal Microbicide Agent PRO 20005 Gel P
Status:
COMPLETED
Status Verified Date:
2003-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether the vaginal gel PRO 20005 causes irritation when used daily
Studies have shown PRO 20005 is safe and well tolerated as a vaginal gel in healthy women who are not sexually active However it was not determined what side effects to skin in the vaginal area there might be in sexually active women
Studies have shown PRO 20005 is safe and well tolerated as a vaginal gel in healthy women who are not sexually active However it was not determined what side effects to skin in the vaginal area there might be in sexually active women
Detailed Description:
Vaginal microbicides are designed to inhibit the sexual transmission of HIV-1 and other disease pathogens Two Phase I clinical trials were conducted to evaluate the safety and tolerance of the gel PRO 20005 in sexually abstinent volunteers Both demonstrated that multiple application of the gel was safe and well tolerated in healthy sexually abstinent women but no clear association between the use of the gel and epithelial disruption was indicated Because genital ulceration and inflammation may increase the risk of HIV infection additional clinical evaluation of PRO 20005 gel is warranted especially for study participants with active sexual behavior
Participants apply PRO 20005 gel intravaginally either once or twice daily for 14 days HIV-negative participants in sexually active cohorts Cohorts A1-A4 are instructed to engage in vaginal intercourse at least twice a week Participants in the HIV-positive cohort Cohort B1 abstain from sexual intercourse for the dosing period Researchers conduct physical exams to see if the gel is having any harmful effects on the womans vulva vagina or cervix Women and their male partners are questioned about gel usage
Participants apply PRO 20005 gel intravaginally either once or twice daily for 14 days HIV-negative participants in sexually active cohorts Cohorts A1-A4 are instructed to engage in vaginal intercourse at least twice a week Participants in the HIV-positive cohort Cohort B1 abstain from sexual intercourse for the dosing period Researchers conduct physical exams to see if the gel is having any harmful effects on the womans vulva vagina or cervix Women and their male partners are questioned about gel usage
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: