Condition category
Infections and Infestations
Date applied
18/11/2005
Date assigned
18/11/2005
Last edited
16/11/2009
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

Prof Michel G. Bergeron

ORCID ID

Contact details

Centre de Rech. en Inf. de L'Univ. Laval
CHUQ - CHUL
2705 boul. Laurier
RC-709
Sainte-Foy
G1V 4G2
Canada
+1 418 654 2705
Michel.G.Bergeron@crchul.ulaval.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-67531

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the safety, tolerance and acceptability of a vaginal gel formulation containing sodium lauryl sulphate (SLS) (invisible condom) in healthy women.

Ethics approval

1. Research Ethics Committee, CHUQ, Quebec, QC approved on the 18th November 2003
2. Cameroon National Ethics Committee approved on the 19th January 2005

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Sodium lauryl sulphate

Primary outcome measures

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 trial start date

01/01/2005

Overall trial end date

31/01/2007

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

452

Participant 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

Recruitment start date

01/01/2005

Recruitment end date

31/01/2007

Locations

Countries of recruitment

Cameroon, Canada

Trial participating centre

Centre de Rech. en Inf. de L'Univ. Laval
Sainte-Foy
G1V 4G2
Canada

Sponsor information

Organisation

Laval University (Canada)

Sponsor details

Cité Universitaire
C.P. 2208
Québec
G1K 7P4
Canada

Sponsor type

University/education

Website

http://www2.ulaval.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-67531)

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19835725

Publication citations

  1. Results

    Mbopi-Keou FX, Trottier S, Omar RF, Nkele NN, Fokoua S, Mbu ER, Giguere JF, Domingo MC, Piret J, Tsague L, Zekeng L, Mwatha A, Mâsse B, Bergeron MG, A randomized, double-blind, placebo-controlled safety and acceptability study of two Invisible Condom formulations in women from Cameroon., Contraception, 2009, 80, 5, 484-492, doi: 10.1016/j.contraception.2009.03.020.

Additional files

Editorial Notes