Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00117884
Status:
TERMINATED
Last Update Posted:
2016-08-19
First Post:
2005-07-01
Brief Title:
Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Randomized Double-blind Placebo-Controlled Dose Response Study to Evaluate 851B Gel Delivered Intravaginally Twice a Week for Two Three-Week Cycles in Women Who Are Positive For High-Risk Genotypes of Human Papillomavirus and Have Mild Cytological Abnormalities
Status:
TERMINATED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of efficacy
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 was to evaluate efficacy of 851B gel over a range of concentrations and dosing regimens on high-risk cervical human papillomavirus infection in women
Detailed Description:
Cervical cancer is caused by infection with specific genotypes of the human papillomavirus referred to as oncogenic or high-risk human papillomavirus Current epidemiologic evidence suggests that 80 of sexually active women will become infected during their lifetime with human papillomavirus and 50 of these infections will be due to high-risk human papillomavirus With US annual rates of cervical cancer now in the range of 13000year a very substantial number of women are left with uncertainty regarding whether their infection will clear spontaneously or progress to cancer
Subjects participating in this study were required to visit the clinic for approximately 15 or 16 visits and maintain a diary of self-dosing and menstruation cycles The total time of participation in this study was approximately 27 months
Subjects participating in this study were required to visit the clinic for approximately 15 or 16 visits and maintain a diary of self-dosing and menstruation cycles The total time of participation in this study was approximately 27 months
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 |
|---|---|---|---|
| U1111-1127-5850 | REGISTRY | WHO | None |