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

Study Overview
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Brief Summary
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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).

Detailed Description
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A phase II, multicentric,randomized, controlled clinical trial.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: a novel Benzalkonium Chloride (BZK) contraceptive gel
* Drug: LELEMI® contraceptive gel containing 50mg nonoxynol-9


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>120 subjects using BenZalkonium Chloride Contraceptive Gel | Drug: a novel Benzalkonium Chloride (BZK) contraceptive gel<br>* insert 1 piece of the gel (containing 18mg BZK) into vagina before every coital act.<br>|
| Active Comparator: 2<br>120 subjects using Nonoxynol-9 contraceptive gel | Drug: LELEMI® contraceptive gel containing 50mg nonoxynol-9<br>* insert 1 piece ofLELEMI® contraceptive gel within half an hour before every coital act<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| contraceptive efficacy |  | March 2004 - November 2005 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acceptability |  | March 2004 - November 2005 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contraceptive efficacy