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CompletedNCT00692952BZKUpdated Jul 10, 2009

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

A Phase 2 interventional study of a novel Benzalkonium Chloride (BZK) contraceptive gel and LELEMI® contraceptive gel containing 50mg nonoxynol-9 in Healthy, sponsored by Shanghai Institute of Planned Parenthood Research. Completed at 3 sites in China. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-10.

Sponsored by Shanghai Institute of Planned Parenthood Research · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Female
01

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).

Read the detailed description

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

02

Conditions studied

  • Healthy

Keywords

  • contraceptive efficacy
03

In context

Lead sponsor

This is the only study on the registry with Shanghai Institute of Planned Parenthood Research as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
240 participants (actual)

Study arms

  • Experimental
    1

    120 subjects using BenZalkonium Chloride Contraceptive Gel

    Drug: a novel Benzalkonium Chloride (BZK) contraceptive gel

  • Active comparator
    2

    120 subjects using Nonoxynol-9 contraceptive gel

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

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

06

What researchers measure

Primary outcomes

  1. contraceptive efficacy

    Time frame: March 2004 - November 2005

Secondary outcomes

  1. acceptability

    Time frame: March 2004 - November 2005

07

Study locations

3 sites
  • 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
    Shanghai, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00692952
Lead sponsor
Shanghai Institute of Planned Parenthood Research
Collaborators
Shanghai Municipal Commission of Health and Family Planning, Fudan University, International Peace Maternity and Child Health Hospital, Shanghai No. 1 Maternity and Child Care Center, Chang Jiang Bio-pharmaceutical Co., Ltd.
First posted
Jun 6, 2008
Start date
Mar 2004
Primary completion
Nov 2005
Completion
Nov 2005
Last update
Jul 10, 2009

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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