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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00692952

Acronym

BZK

Enrollment

240

Registered

2008-06-06

Start date

2004-03-31

Completion date

2005-11-30

Last updated

2009-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

contraceptive efficacy

Brief 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).

Detailed description

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

Interventions

DRUGa novel Benzalkonium Chloride (BZK) contraceptive gel

insert 1 piece of the gel (containing 18mg BZK) into vagina before every coital act.

DRUGLELEMI® contraceptive gel containing 50mg nonoxynol-9

insert 1 piece ofLELEMI® contraceptive gel within half an hour before every coital act

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
contraceptive efficacy	March 2004 - November 2005

Secondary

Measure	Time frame
acceptability	March 2004 - November 2005

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026