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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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