Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00213057
Status:
COMPLETED
Last Update Posted:
2017-08-14
First Post:
2005-09-13
Brief Title:
Safety and Acceptability of Carraguard Among HIV-negative Couples in Thailand
Sponsor:
Population Council
Organization:
Population Council
Study Overview
Official Title:
A Randomized Placebo-controlled Double-blind Trial to Assess Expanded Safety and Acceptability of Carraguard PC-515 Vaginal Gel Among Heterosexual Couples in Chiang Rai
Status:
COMPLETED
Status Verified Date:
2017-08
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 primary aims of the study were to assess the safety and acceptability of Carraguard applied vaginally prior to sexual intercourse for six months in both women and men and to examine several dimensions of acceptability Secondary aims were to gauge reactions to a non-contraceptive microbicide to assess use dynamics among Thai couples and to observe preliminary indications of sexually transmitted infections and reproductive tract infections averted
The hypothesis was that Carraguard would cause little or no significant irritation including lesions and that women and men would find Carraguard acceptable
The hypothesis was that Carraguard would cause little or no significant irritation including lesions and that women and men would find Carraguard acceptable
Detailed Description:
Carraguard PC-515 the Population Councils lead candidate microbicide was tested in a triple-masked randomized placebo-controlled trial fielded in one site in Chiang Rai northern Thailand The primary aims of the study were to assess Carraguards safety toxicity in both men and women - including signs of local irritation such as itching or burning changes in vaginal flora women and incidence of abnormal external genital vaginal women and cervical findings women - when applied vaginally prior to intercourse for 6 months to evaluate acceptability to gauge mens and womens reactions to a non-contraceptive microbicide and to explore microbicide use dynamics in a Thai population
Secondary aims were to investigate sexually transmitted infections averted - including HIV C trachomatis N gonorrhoeae T vaginalis and T pallidum preliminary indications in men and women bacterial vaginosis and candidaisis in women and balanitis in men and effect on cervical cytology
Secondary aims were to investigate sexually transmitted infections averted - including HIV C trachomatis N gonorrhoeae T vaginalis and T pallidum preliminary indications in men and women bacterial vaginosis and candidaisis in women and balanitis in men and effect on cervical cytology
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 |
|---|---|---|---|
| CDC Protocol 2968 | None | None | None |