Status:
COMPLETED
Effectiveness of BenZalkonium Chloride Gel as Vaginal Contraceptive: a Multicentric Randomized Controlled Trial
Lead Sponsor:
Shanghai Institute of Planned Parenthood Research
Collaborating Sponsors:
Shanghai Municipal Commission of Health and Family Planning
Fudan University
Conditions:
Healthy
Eligibility:
FEMALE
20-45 years
Phase:
PHASE2
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...
Detailed Description
A phase II, multicentric,randomized, controlled clinical trial.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00692952
Start Date
March 1 2004
End Date
November 1 2005
Last Update
July 10 2009
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Gynecology and Obstetrics Hospital of Fudan University
Shanghai, China
2
International Peace Maternity and Child Care Center
Shanghai, China
3
Shanghai No. 1 Maternity and Child Care Center
Shanghai, China