A phase I/II study on the safety, tolerance and acceptability of a vaginal gel containing sodium lauryl sulphate (invisible condom) in healthy subjects
| ISRCTN | ISRCTN27146131 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27146131 |
| Secondary identifying numbers | MCT-67531 |
- Submission date
- 18/11/2005
- Registration date
- 18/11/2005
- Last edited
- 16/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Michel G. Bergeron
Scientific
Scientific
Centre de Rech. en Inf. de L'Univ. Laval
CHUQ - CHUL
2705 boul. Laurier, RC-709
Sainte-Foy
G1V 4G2
Canada
| Phone | +1 418 654 2705 |
|---|---|
| Michel.G.Bergeron@crchul.ulaval.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To evaluate the safety, tolerance and acceptability of a vaginal gel formulation containing sodium lauryl sulphate (SLS) (invisible condom) in healthy women. |
| Ethics approval(s) | 1. Research Ethics Committee, CHUQ, Quebec, QC approved on the 18th November 2003 2. Cameroon National Ethics Committee approved on the 19th January 2005 |
| Health condition(s) or problem(s) studied | Prevention of sexual transmitted infections (STIs) including human immunodeficiency virus (HIV) |
| Intervention | Trial groups: Group 1: Gel alone Group 2: Gel plus SLS Group 3: Placebo The study will be divided in two parts. Part A is a short-term study using escalating gel applications (1 x, 2 x and 3 x) daily for 2 weeks. In Part B, they will receive the gel twice daily for 2 months. Trial details received 12 Sept 2005 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Sodium lauryl sulphate |
| Primary outcome measure | 1. Safety and tolerance measured at all visits by gynecological and colposcopic examinations 2. Nugent score 3. Clinical laboratory safety tests |
| Secondary outcome measures | Acceptability measured at the end of gel application period by acceptability questionnaire |
| Overall study start date | 01/01/2005 |
| Completion date | 31/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 452 |
| Key inclusion criteria | 1. Signed an informed consent 2. Healthy female subjects aged between 18 to 49 years 3. Normal physical and gynaecological examinations 4. Normal colposcopic examination 5. Have regular menstrual cycle with 21 - 40 days between menses 6. Human immunodeficiency virus (HIV)-negative subjects and at low risk of acquiring HIV 7. At low risk of getting sexually transmitted diseases (STDs), i.e., sexually abstinent or having history of protected sexual intercourse or having a stable sexual partner 8 Agreeing to abstain from sexual intercourse from screening to the end of the study (for sexually abstinent subjects) 9. Agreeing to have a minimum of four sexual intercourses for each period of 2 weeks of gel application (for sexually active subjects) |
| Key exclusion criteria | 1. Clinically significant abnormal physical and/or gynaecological examination 2. Clinically significant abnormal laboratory findings 3. Allergy to applicator material (polyethylene) or to gel polymer (polyoxyethylene - polyoxypropylene) or to latex 4. Participation in any investigational study involving drugs, vaccines or microbicides in the last 30 days or participation in a study involving the invisible condom 5. History of toxic shock syndrome 6. HIV infection 7. Bacterial vaginosis or Candida or Trichomonas at time of screening 8. STDs (gonorrheae, chlamydia, syphilis, genital herpes, chancroid) at time of screening 9. Breakthrough menstrual bleeding, or vaginal bleeding during or following sexual intercourse, in the last 3 months 10. Intravenous (IV) drug use except for medical reasons in the last year 11. Pregnant at enrolment or breast-feeding 12. Having received antibiotics in the last 14 days 13. Subjects considered as unreliable or unable to understand or follow the study protocol directions 14. Use of an intrauterine device |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/01/2007 |
Locations
Countries of recruitment
- Cameroon
- Canada
Study participating centre
Centre de Rech. en Inf. de L'Univ. Laval
Sainte-Foy
G1V 4G2
Canada
G1V 4G2
Canada
Sponsor information
Laval University (Canada)
University/education
University/education
Cité Universitaire
C.P. 2208
Québec
G1K 7P4
Canada
| Website | http://www2.ulaval.ca/ |
|---|---|
"ROR" |
https://ror.org/04sjchr03 |
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-67531)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2009 | Yes | No |
