MedTrace Logo

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

NCT00692952 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2009-07-10

No results posted yet for this study

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).

Conditions

  • Healthy

Interventions

DRUG

a novel Benzalkonium Chloride (BZK) contraceptive gel

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

DRUG

LELEMI® contraceptive gel containing 50mg nonoxynol-9

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

Sponsors & Collaborators

  • Shanghai Municipal Commission of Health and Family Planning

    collaborator OTHER

  • Fudan University

    collaborator OTHER

  • International Peace Maternity and Child Health Hospital

    collaborator OTHER

  • Shanghai No. 1 Maternity and Child Care Center

    collaborator UNKNOWN

  • Chang Jiang Bio-pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Shanghai Institute of Planned Parenthood Research

    lead OTHER_GOV

Principal Investigators

  • Jinxun XU, MD · Shanghai Municipal Commission of Health and Family Planning

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2005-11-30
Completion
2005-11-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00692952 on ClinicalTrials.gov