Effectiveness of BenZalkonium Chloride Gel as Vaginal Contraceptive: a Multicentric Randomized Controlled Trial

Effectiveness of BenZalkonium Chloride Gel as Vaginal Contraceptive: a Multicentric Randomized Controlled Trial

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.

Inclusion Criteria:

• at risk for pregnancy and desiring contraception
• having regular menstrual cycle (21-35 days)
• at low risk for HIV or other sexually transmitted infection
• sexually active
• use the test products as their primary method of contraception
• keep a diary of coital activity, product use, and adverse events

Exclusion Criteria:

• diagnosis of any vaginal infection or any symptom of STDs at baseline
• known allergy or hypersensitivity to N-9 or BZK
• menopause for more than one month
• breastfeeding
• vaginal bleeding with unknown reasons
• genitourinary system anomaly
• hysteroptosis II or severe cystocele
• moderate to severe erosion of cervix
• malignant reproductive system tumors