drugset / Trial / NCT00692952
Effectiveness of BenZalkonium Chloride Gel as Vaginal Contraceptive: a Multicentric Randomized Controlled Trial
Phase 2
Completed
240 enrolled
Shanghai Institute of Planned Parenthood Research
Chang Jiang Bio-pharmaceutical Co., Ltd. · collabFudan University · collabInternational Peace Maternity and Child Health Hospital · collabShanghai Municipal Commission of Health and Family Planning · collabShanghai No. 1 Maternity and Child Care Center · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
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).
Timeline
- Start
- 2004-03
- Primary completion
- 2005-11
- Completion
- 2005-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BENZALKONIUM | Small molecule | 18 mg | Other |
| Comparator | Nonoxynol-9 | Small molecule | 50 mg | Other |
Indications
No indication recorded.