Contraceptive Effectiveness Trial of Cellulose Sulfate Gel
This study will evaluate the contraceptive effectiveness of cellulose sulfate vaginal gel in preventing pregnancy when used for 6 months.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Non-Comparative Contraceptive Effectiveness Trial of Cellulose Sulfate (CS) Gel|
- 1. To estimate the cumulative probability of pregnancy for six months and six cycles of typical use of the CS gel.
- 2. To estimate the cumulative probability of pregnancy for six cycles of consistent use of the CS gel.
- 3. To estimate the cumulative probability of study discontinuation through six months of CS gel use.
- 1. To assess the acceptability of CS gel among female and male users
- 2. To assess the consistency of use of CS gel among study participants
- 3. To estimate the frequency of abnormal cytology, candidiasis, urinary tract infections, bacterial vaginosis, and genital irritation during six months of CS gel use.
- 4. To identify any serious adverse events or patterns of unanticipated adverse events related to the use of CS gel.
|Study Start Date:||January 2005|
|Estimated Study Completion Date:||October 2005|
Cellulose sulfate has been shown in preclinical studies to have both contraceptive and antimicrobial properties. Clinical safety studies have shown it to be safe for use up to six days in women and 7 days in men, and ongoing studies are assessing its safety for twice daily use for 14 days in women. This study will evaluate its contraceptive effectiveness in women who use it for 6 months.