Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136643
Status:
COMPLETED
Last Update Posted:
2007-10-10
First Post:
2005-08-26
Brief Title:
Safety Tolerance and Acceptability Trial of the Invisible Condom in Healthy Women
Sponsor:
Laval University
Organization:
Laval University
Study Overview
Official Title:
A Phase III Randomized Double-Blind Placebo-Controlled Study of the Safety Tolerance and Acceptability of a Vaginal Gel Containing Sodium Lauryl Sulfate Invisible Condom in Healthy Female Subjects
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objectives of this clinical study are to evaluate the extended safety tolerance and acceptability of a vaginal gel formulation when applied in 452 healthy women volunteers This vaginal formulation was shown to be well tolerated in a previous smaller clinical study The formulation is being developed as a microbicide for the prevention of sexually transmitted infections STIs including HIV
Detailed Description:
Objectives The objectives of this Phase III clinical trial are to evaluate the safety tolerance and acceptability of a gel formulation containing sodium lauryl sulfate SLS compared to gel alone and placebo when applied intravaginally in healthy volunteers
Design In part A of the protocol three groups gel alone gel plus SLS and placebo will be tested for safety tolerance and acceptability when applied intravaginally once twice or three times daily for 14 days in 252 healthy subjects The volunteers will be divided as follow 36 sexually abstinent healthy subjects 12 per group will apply the gel gel plus SLS or the placebo once daily for 14 days 72 sexually active healthy subjects 24 per group will apply the gel gel plus SLS or the placebo once daily for 14 days 72 sexually active healthy subjects 24 per group will apply the gel gel plus SLS or the placebo twice daily for 14 days and 72 sexually active healthy subjects 24 per group will apply the gel gel plus SLS or the placebo three times daily for 14 days The gel will be applied between menses For the sexually active group the gel should be applied less than 1 hour before sexual intercourse if planned Subjects will have vaginal intercourse a minimum of 4 times in a 2-week period of gel application
In part B of the protocol the extended safety of the gel alone gel plus SLS and placebo will be studied when applied intravaginally twice daily for 8 weeks in sexually active healthy subjects In this part B actually represents Phase II of the trial 80 healthy sexually active subjects for the gel alone group and 80 subjects for the gel SLS group and 40 subjects for the placebo group will be studied The part B involves the participation of a total of 200 subjects Subjects will have vaginal intercourse a minimum of 4 times in a 2-week period of gel application The gel will be applied between menses The gel should be applied less than 1 hour before sexual intercourse if planned but no more than twice a day
Design In part A of the protocol three groups gel alone gel plus SLS and placebo will be tested for safety tolerance and acceptability when applied intravaginally once twice or three times daily for 14 days in 252 healthy subjects The volunteers will be divided as follow 36 sexually abstinent healthy subjects 12 per group will apply the gel gel plus SLS or the placebo once daily for 14 days 72 sexually active healthy subjects 24 per group will apply the gel gel plus SLS or the placebo once daily for 14 days 72 sexually active healthy subjects 24 per group will apply the gel gel plus SLS or the placebo twice daily for 14 days and 72 sexually active healthy subjects 24 per group will apply the gel gel plus SLS or the placebo three times daily for 14 days The gel will be applied between menses For the sexually active group the gel should be applied less than 1 hour before sexual intercourse if planned Subjects will have vaginal intercourse a minimum of 4 times in a 2-week period of gel application
In part B of the protocol the extended safety of the gel alone gel plus SLS and placebo will be studied when applied intravaginally twice daily for 8 weeks in sexually active healthy subjects In this part B actually represents Phase II of the trial 80 healthy sexually active subjects for the gel alone group and 80 subjects for the gel SLS group and 40 subjects for the placebo group will be studied The part B involves the participation of a total of 200 subjects Subjects will have vaginal intercourse a minimum of 4 times in a 2-week period of gel application The gel will be applied between menses The gel should be applied less than 1 hour before sexual intercourse if planned but no more than twice a day
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FRN 67531 | None | None | None |