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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 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 |
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 ]
Secondary Outcome Measures:
- acceptability [ Time Frame: March 2004 - November 2005 ]
| 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) |
| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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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 |
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 19, 2017