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

Phase 2

Completed

• Conditions: Healthy
• Interventions: Drug: a novel Benzalkonium Chloride (BZK) contraceptive gel; Drug: LELEMI® contraceptive gel containing 50mg nonoxynol-9

• Registration Number: NCT00692952
• Lead Sponsor: Shanghai Institute of Planned Parenthood Research

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).

Detailed Description

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

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2008-06
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Last Update Submitted: 2009-07-09
• Last Update Posted: 2009-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	a novel Benzalkonium Chloride (BZK) contraceptive gel	120 subjects using BenZalkonium Chloride Contraceptive Gel
2	LELEMI® contraceptive gel containing 50mg nonoxynol-9	120 subjects using Nonoxynol-9 contraceptive gel

Primary Outcome Measures

Name	Time	Method
contraceptive efficacy	March 2004 - November 2005

Secondary Outcome Measures

Name	Time	Method
acceptability	March 2004 - November 2005

Trial Locations

Locations (3)

Gynecology and Obstetrics Hospital of Fudan University; 🇨🇳 Shanghai, China

Shanghai No. 1 Maternity and Child Care Center; 🇨🇳 Shanghai, China

International Peace Maternity and Child Care Center; 🇨🇳 Shanghai, China