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Completed

NCT Number: NCT00692952

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

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).

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Gynecology and Obstetrics Hospital of Fudan University, Shanghai, China

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

a novel Benzalkonium Chloride (BZK) contraceptive gel

Drug

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

LELEMI® contraceptive gel containing 50mg nonoxynol-9

Drug

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

Primary outcomes

  1. contraceptive efficacy

    Time frame: March 2004 - November 2005

Secondary outcomes

  1. acceptability

    Time frame: March 2004 - November 2005

Sponsors and collaborators

Lead sponsor

Shanghai Institute of Planned Parenthood Research

Other Gov

Collaborators

  • Chang Jiang Bio-pharmaceutical Co., Ltd.
  • 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

Registry information

Acronym: BZK

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jun 6, 2008
Registry last updated
Jul 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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