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

This study has been completed.
Sponsor:
Collaborators:
Shanghai Municipal Commission of Population and Family Planning
Fudan University
International Peace Maternity and Child Care Center
Shanghai No. 1 Maternity and Child Care Center
Chang Jiang Bio-pharmaceutical Co., Ltd.
Information provided by:
Shanghai Institute of Planned Parenthood Research
ClinicalTrials.gov Identifier:
NCT00692952
First received: June 4, 2008
Last updated: July 9, 2009
Last verified: June 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effectiveness of BenZalkonium Chloride Gel as Vaginal Contraceptive: a Multicentric Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Shanghai Institute of Planned Parenthood Research:

Primary Outcome Measures:
  • contraceptive efficacy [ Time Frame: March 2004 - November 2005 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • acceptability [ Time Frame: March 2004 - November 2005 ] [ Designated as safety issue: Yes ]

Enrollment: 240
Study Start Date: March 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Care Center
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

No publications provided

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
Study First Received: June 4, 2008
Last Updated: July 9, 2009
Health Authority: China: Food and Drug Administration

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
Pharmacologic Actions
Therapeutic Uses
Anti-Infective Agents, Local
Anti-Infective Agents
Spermatocidal Agents
Antispermatogenic Agents
Contraceptive Agents, Female
Contraceptive Agents, Male

ClinicalTrials.gov processed this record on September 18, 2014