Expanded safety and acceptability study of 6% cellulose sulphate
| ISRCTN | ISRCTN20671128 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20671128 |
| Secondary identifying numbers | WHO/HRP ID: A15006 |
- Submission date
- 19/03/2004
- Registration date
- 01/04/2004
- Last edited
- 10/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Isaac Malonza
Scientific
Scientific
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| malonzai@who.int |
Study information
| Study design | A phase I randomised, closed label, comparative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Expanded safety and acceptability study of 6% cellulose sulphate |
| Study objectives | Local tolerance and acceptability of cellulose sulphate (CS) gel applied vaginally twice daily for seven days. |
| Ethics approval(s) | The study protocol was approved by scientific and ethics review committees at each implementing centre and the World Health Organization. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/12/2001 |
| Completion date | 01/07/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 180 |
| Total final enrolment | 180 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2001 |
| Date of final enrolment | 01/07/2003 |
Locations
Countries of recruitment
- India
- Nigeria
- Switzerland
- Uganda
Study participating centre
World Health Organization
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Sponsor information
UNDP/UNFPA/WHO/World Bank - Special Programme of Research, Development and Research Training in Human Reproduction
Research organisation
Research organisation
World Health Organization
20, Avenue Appia
Geneva-27
CH-1211
Switzerland
| Website | http://www.who.int/reproductive-health/hrp/ |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
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)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 02/12/2005 | Yes | No |
Editorial Notes
10/11/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
