Effectiveness of BenZalkonium Chloride Gel as Vaginal Contraceptive: a Multicentric Randomized Controlled Trial (BZK)
This study has been completed.
Sponsor:
Shanghai Institute of Planned Parenthood Research
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
ClinicalTrials.gov Identifier:
NCT00692952
First received: June 4, 2008
Last updated: July 9, 2009
Last verified: June 2008
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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 (Adult) |
| 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
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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
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 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
| 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 Anti-Infective Agents, Local |
Anti-Infective Agents Spermatocidal Agents Antispermatogenic Agents Contraceptive Agents, Female Contraceptive Agents, Male |
ClinicalTrials.gov processed this record on September 23, 2016