Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274261
Status:
COMPLETED
Last Update Posted:
2018-05-01
First Post:
2006-01-06
Brief Title:
Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol
Sponsor:
Health Decisions
Organization:
Health Decisions
Study Overview
Official Title:
A Phase IIIII Multicenter Randomized Double-masked Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol
Status:
COMPLETED
Status Verified Date:
2018-04
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:
This is a multicenter randomized double-masked controlled phase III study of repeated use of C31G vaginal gel compared to Conceptrol Vaginal Gel as the primary method of contraception over six months 183 days and at least six cycles of use In addition there is an opportunity for subjects to continue with study treatment for up to twelve months 365 days and twelve cycles of treatment upon completion of the first six months of treatment
Detailed Description:
Approximately 85 of American women 52 million between the ages of 15 and 44 are sexually active Approximately two-thirds or 38 million women use some form of birth control andor STD prevention With growing awareness of the risk of STDs increasing numbers of women will require contraceptive methods that provide protection against STDs in addition to providing the basic contraceptive function Currently there is no single reasonably effective method to achieve both ends Condoms both male and female present problems of acceptability for the partners of many at-risk women and thus cannot be considered an effective contraceptive and STD preventive for many people A spermicide that also has the ability to prevent transmission of STDs would be a major advance and of tremendous value to women worldwide
C31G is an effective spermicide with in vitro activity equal to that of N-9 C31G has been found to be a broad-spectrum antibacterial agent in vitro or in animals active against both gram-positive and gram-negative organisms including chlamydia and a range of antibiotic resistant strains It is also active against enveloped viruses including HIV and HSV Thus the primary objective of the study is to determine the contraceptive efficacy of C31G vaginal gel compared to Conceptrol Vaginal Gel The secondary objectives are to determine the safety and acceptability of the compounds with use over a period of six months or twelve months Additional evaluations include the incidence of urinary tract infections UTI bacterial vaginosis BV and yeast vaginitis following the use of C31G vaginal gel compared to Conceptrol Vaginal Gel
C31G is an effective spermicide with in vitro activity equal to that of N-9 C31G has been found to be a broad-spectrum antibacterial agent in vitro or in animals active against both gram-positive and gram-negative organisms including chlamydia and a range of antibiotic resistant strains It is also active against enveloped viruses including HIV and HSV Thus the primary objective of the study is to determine the contraceptive efficacy of C31G vaginal gel compared to Conceptrol Vaginal Gel The secondary objectives are to determine the safety and acceptability of the compounds with use over a period of six months or twelve months Additional evaluations include the incidence of urinary tract infections UTI bacterial vaginosis BV and yeast vaginitis following the use of C31G vaginal gel compared to Conceptrol Vaginal Gel
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 |
|---|---|---|---|
| HHSN2752004033661 | None | None | None |