Effectiveness of BenZalkonium Chloride Gel as Vaginal Contraceptive: a Multicentric Randomized Controlled Trial

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shanghai Institute of Planned Parenthood Research
• Collaborators: Chang Jiang Bio-pharmaceutical Co., Ltd.; Fudan University; International Peace Maternity and Child Health Hospital; Shanghai Municipal Commission of Health and Family Planning; Shanghai Municipal Commission of Population and Family Planning; Shanghai No. 1 Maternity and Child Care Center
• Treatments: Benzalkonium Compounds; Contraceptive Agents; Nonoxynol

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