Sexually transmitted infection (STI) prevention Urological and Genital Diseases Sexually transmitted infection
Conditions
Interventions
1. Test groups using Cellulose Sulphate (CS) gel with or without concurrent intercourse
2. Control groups using K-Y jelly with or without concurrent intercourse
Total
Sponsors
UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy, sexually abstinent and sexually active women 2. Considered to be at low risk for human immunodeficiency virus (HIV) 3. Recruited from family planning clinics and local communities in Kampala (Uganda), Mumbai (India), and Sagamu (Nigeria) 4. Aged between 18 and 50 years 5. Had regular menstrual cycles, or were on injectable contraceptives and amenorrhoeic for at least 6 months 6. Were not at risk for pregnancy (because of tubal ligation, steroidal contraceptives, or abstinence) 7. Willing to adhere to the study protocol
Exclusion criteria
Exclusion criteria: 1. Known to have an allergy to any component of CS gel or K-Y Jelly or condoms (cohort II only) 2. Currently pregnant or within 2 months from last pregnancy outcome 3. Known to abuse drug or alcohol 4. Had evidence of an infection with Trichomonas vaginalis, Candidiasis or bacterial vaginosis which did not resolve with treatment or if they had gonorrhoea or a chlamydial infection 5. Had a history of herpes or condylomata within the past 6 months 6. Had non-iatrogenic abnormal colposcopy findings involving deep disruption of the genital epithelium at enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of women who experienced any signs and/or symptoms of genital irritation as reported by volunteers at any time during follow-up or as determined by naked eye examination of the genitalia, on colposcopy or microbiologic tests. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Countries
India, Nigeria, Switzerland, Uganda
Outcome results
None listed