Contact information
Type
Scientific
Primary contact
Dr Isaac Malonza
ORCID ID
Contact details
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
malonzai@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
WHO/HRP ID: A15006
Study information
Scientific title
Acronym
Study hypothesis
Local tolerance and acceptability of cellulose sulphate (CS) gel applied vaginally twice daily for seven days.
Ethics approval
The study protocol was approved by scientific and ethics review committees at each implementing centre and the World Health Organization.
Study design
A phase I randomised, closed label, comparative study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Sexually transmitted infection (STI) prevention
Intervention
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 duration of involvement in the study, including screening, admission, completion and follow up, is approximately one month per subject.
Intervention type
Drug
Phase
Phase I
Drug names
Cellulose sulphate (CS) gel
Primary outcome measure
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 outcome measures
Adverse events
Overall trial start date
01/12/2001
Overall trial end date
01/07/2003
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
180
Participant 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
Recruitment start date
01/12/2001
Recruitment end date
01/07/2003
Locations
Countries of recruitment
India, Nigeria, Uganda
Trial participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
Sponsor details
World Health Organization
20
Avenue Appia
Geneva-27
CH-1211
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
United Nations Development Programme (UNDP)/United Nations Population Fund (UNFPA)/World Health Organization (WHO)/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction (HRP)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Publication citations
-
Results
Malonza IM, Mirembe F, Nakabiito C, Odusoga LO, Osinupebi OA, Hazari K, Chitlange S, Ali MM, Callahan M, Van Damme L, Expanded Phase I safety and acceptability study of 6% cellulose sulfate vaginal gel., AIDS, 2005, 19, 18, 2157-2163.