Effectiveness of BenZalKonium chloride gel as vaginal contraceptive: a multicentric randomised controlled trial

Phase 2

Completed

• Conditions: Contraceptive effectiveness; Pregnancy and Childbirth; Contraception

• Registration Number: ISRCTN16203579
• Lead Sponsor: Shanghai Institute of Planned Parenthood Research (China)

Brief Summary

1. 2012 results in https://www.ncbi.nlm.nih.gov/pubmed/23089047 (added 28/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-11-01
• Study Start: 2008-05-29
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Eligibility requirements included:
1. Sexually active female
2. Aged 20 - 45 years old
3. Presumably fertile based on at least one delivery record
4. At risk for pregnancy and desiring contraception
5. Having regular menstrual cycle (21 - 35 days) and at least three normal menstrual cycles since the last pregnancy, abortion or hormone contraceptive use
6. Be willing to engage in at least four acts of sexual intercourse per month
7. Use the test products as their primary method of contraception
8. Keep a diary of coital activity, product use, and adverse events
9. At low risk for human immunodeficiency virus (HIV) or other sexually transmitted infection, which was defined as having a single sexual partner (for at least six months prior to study initiation)
10. The subject's sexual partner should not be presumably infertile, have a known allergy to BZK or N-9, or have been treated for sexually transmitted diseases (STDs) within six months prior to study entry

Exclusion Criteria

Exclusion criteria included:
1. Diagnosis of any vaginal infection or any symptom of STDs at baseline
2. Known allergy or hypersensitivity to N-9 or BZK
3. Menopause for more than one month
4. Breastfeeding
5. Vaginal bleeding with unknown reasons
6. Recurrent vaginitis or urinary infection
7. Genitourinary system anomaly
8. Hysteroptosis II or severe cystocele
9. Moderate to severe erosion of cervix
10. Malignant reproductive system tumours

Study & Design

• Study Type: Interventional
• Study Design: Not specified