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

July 9, 2009 updated by: Shanghai Institute of Planned Parenthood Research
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Gynecology and obstetrics hospital of fudan university
      • Shanghai, China
        • International Peace Maternity and Child Care Center
      • Shanghai, China
        • Shanghai No. 1 Maternity and Child Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
contraceptive efficacy
Time Frame: March 2004 - November 2005
March 2004 - November 2005

Secondary Outcome Measures

Outcome Measure
Time Frame
acceptability
Time Frame: March 2004 - November 2005
March 2004 - November 2005

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Institute of Planned Parenthood Research

Collaborators

Fudan University
International Peace Maternity and Child Health Hospital
Shanghai Municipal Commission of Health and Family Planning
Shanghai No. 1 Maternity and Child Care Center
Chang Jiang Bio-pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Jinxun XU, MD, Shanghai Municipal Commission of Health and Family Planning

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

June 4, 2008

First Submitted That Met QC Criteria

June 5, 2008

First Posted (Estimate)

June 6, 2008

Study Record Updates

Last Update Posted (Estimate)

July 10, 2009

Last Update Submitted That Met QC Criteria

July 9, 2009

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • China FDA 2003L02778
  • ISRCTN16203579

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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