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

Shanghai Institute of Planned Parenthood Research

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Drug: a novel Benzalkonium Chloride (BZK) contraceptive gel; Drug: LELEMI® contraceptive gel containing 50mg nonoxynol-9

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00692952

China FDA 2003L02778

ISRCTN16203579

Details and patient eligibility

About

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).

Full description

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

Enrollment: 240 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

1

Experimental group

Description:

120 subjects using BenZalkonium Chloride Contraceptive Gel

Treatment:

Drug: a novel Benzalkonium Chloride (BZK) contraceptive gel

2

Active Comparator group

Description:

120 subjects using Nonoxynol-9 contraceptive gel

Treatment:

Drug: LELEMI® contraceptive gel containing 50mg nonoxynol-9