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
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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 |
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 |

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 |
- contraceptive efficacy [ Time Frame: March 2004 - November 2005 ]
- acceptability [ Time Frame: March 2004 - November 2005 ]

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

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
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 |
Principal Investigator: | Jinxun XU, MD | Shanghai Municipal Commission of Health and Family Planning |
Responsible Party: | Prof. Dr. Xuncheng DING, Shanghai Institute of Planned Parenthood Research |
ClinicalTrials.gov Identifier: | NCT00692952 |
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 |
contraceptive efficacy |
Benzalkonium Compounds Contraceptive Agents Nonoxynol Reproductive Control Agents Physiological Effects of Drugs Anti-Infective Agents, Local |
Anti-Infective Agents Spermatocidal Agents Antispermatogenic Agents Contraceptive Agents, Female Contraceptive Agents, Male |