Contraceptive effectiveness Pregnancy and Childbirth Contraception
Conditions
Interventions
Participants received either benzalkonium chloride gel or nonoxynol-9 gel as their primary method of contraception. All treatment arms were followed for six months.
The test drug, Ben
Sponsors
Shanghai Institute of Planned Parenthood Research (China)
Eligibility
Sex/Gender
Female
Inclusion criteria
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Contraceptive effectiveness. Outcomes were assessed at 2, 4 and 6-month follow-up visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety, evaluated based on gynaecological examination, cytobacteriological examinations, blood test, urine test, reporting adverse events, and termination due to medical reasons. An adverse event was a change in health status from that at baseline, regardless of its possible relationship with the product, consistent with good clinical practice guidelines. 2. Product acceptability, assessed through a standard questionnaire Outcomes were assessed at 2, 4 and 6-month follow-up visits. | — |
Countries
China
Outcome results
None listed