Contraceptive Effectiveness Trial of Cellulose Sulfate Gel
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|ClinicalTrials.gov Identifier: NCT00255294|
Recruitment Status : Completed
First Posted : November 18, 2005
Last Update Posted : November 18, 2005
|Condition or disease||Intervention/treatment||Phase|
|Contraception||Drug: Cellulose sulfate vaginal gel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-Comparative Contraceptive Effectiveness Trial of Cellulose Sulfate (CS) Gel|
|Study Start Date :||January 2005|
|Study Completion Date :||October 2005|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00255294
|United States, California|
|California Family Health Council|
|Los Angeles, California, United States, 90010|
|Study Director:||Christine K Mauck, MD||CONRAD|