A multicentric clinical trial in three Chinese Maternal and Child Hospitals was conducted to evaluate the efficacy, safety and acceptability of newly-developed vaginal contraceptive gel, the optimized benzalkonium chloride (BZK) gel containing 18mg BZK, with comparison to a currently marketed (in China)contraceptive gel LELEMI® containing 50mg Nonoxynol-9 (N-9).
A phase II, multicentric,randomized, controlled clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
240
insert 1 piece of the gel (containing 18mg BZK) into vagina before every coital act.
insert 1 piece ofLELEMI® contraceptive gel within half an hour before every coital act
Gynecology and Obstetrics Hospital of Fudan University
Shanghai, China
International Peace Maternity and Child Care Center
Shanghai, China
Shanghai No. 1 Maternity and Child Care Center
Shanghai, China
contraceptive efficacy
Time frame: March 2004 - November 2005
acceptability
Time frame: March 2004 - November 2005
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