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

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ClinicalTrials.gov Identifier: NCT00692952
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : July 10, 2009
Sponsor:
Collaborators:
Shanghai Municipal Commission of Population 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.
Information provided by:
Shanghai Institute of Planned Parenthood Research

Study Description
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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).

Condition or disease Intervention/treatment Phase
Healthy Drug: a novel Benzalkonium Chloride (BZK) contraceptive gel Drug: LELEMI® contraceptive gel containing 50mg nonoxynol-9 Phase 2

Detailed Description:
A phase II, multicentric,randomized, controlled clinical trial.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effectiveness of BenZalkonium Chloride Gel as Vaginal Contraceptive: a Multicentric Randomized Controlled Trial
Study Start Date : March 2004
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. contraceptive efficacy [ Time Frame: March 2004 - November 2005 ]

Secondary Outcome Measures :
  1. acceptability [ Time Frame: March 2004 - November 2005 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692952


Locations
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
Shanghai, China
Sponsors and Collaborators
Shanghai Institute of Planned Parenthood Research
Shanghai Municipal Commission of Population 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.
Investigators
Principal Investigator: Jinxun XU, MD Shanghai Municipal Commission of Population and Family Planning
More Information
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Responsible Party: Prof. Dr. Xuncheng DING, Shanghai Institute of Planned Parenthood Research
ClinicalTrials.gov Identifier: NCT00692952     History of Changes
Other Study ID Numbers: China FDA 2003L02778
ISRCTN16203579
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: July 10, 2009
Last Verified: June 2008

Keywords provided by Shanghai Institute of Planned Parenthood Research:
contraceptive efficacy

Additional relevant MeSH terms:
Contraceptive Agents
Nonoxynol
Benzalkonium Compounds
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
 Anti-Infective Agents
Spermatocidal Agents
Antispermatogenic Agents
Contraceptive Agents, Female
Contraceptive Agents, Male