NCT00692952CompletedPhase 2
Effectiveness of BenZalkonium Chloride Gel as Vaginal Contraceptive: a Multicentric Randomized Controlled Trial
Shanghai Institute of Planned Parenthood Research3 sites in 1 country240 target enrollmentStarted: March 2004Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 240
- Locations
- 3
- Primary Endpoint
- contraceptive efficacy
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- 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
Arms & Interventions
1
Experimental
120 subjects using BenZalkonium Chloride Contraceptive Gel
Intervention: a novel Benzalkonium Chloride (BZK) contraceptive gel (Drug)
2
Active Comparator
120 subjects using Nonoxynol-9 contraceptive gel
Intervention: LELEMI® contraceptive gel containing 50mg nonoxynol-9 (Drug)
Outcomes
Primary Outcomes
contraceptive efficacy
Time Frame: March 2004 - November 2005
Secondary Outcomes
- acceptability(March 2004 - November 2005)
Investigators
Study Sites (3)
Loading locations...
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