Condition category
Urological and Genital Diseases
Date applied
19/03/2004
Date assigned
01/04/2004
Last edited
28/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.who.int/reproductive-health/hrp/

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

Results - basic reporting

Publication summary

Results in:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16284466

Publication citations

  1. 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.

Additional files

Editorial Notes