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| [ Print-friendly version ] |
| Carrageenan Against Transmission of Cervical Human papillomavirus (HPV) |
| ISRCTN | ISRCTN96104919 |
| DOI | 10.1186/ISRCTN96104919 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Carrageenan Against Transmission of Cervical Human papillomavirus (HPV) |
| Scientific title | Randomized controlled trial evaluating the efficacy of carrageenan as a topical microbicide against HPV Infection |
| Acronym | CATCH |
| Serial number at source | N/A |
| Study hypothesis |
1. To evaluate the efficacy of carrageenan in reducing genital HPV incidence, i.e., in preventing new HPV infection, in young sexually active women.
2. To evaluate the efficacy of carrageenan in reducing genital HPV prevalence, i.e., in accelerating clearance of existing infections, in young sexually active women. |
| Lay summary | Lay summary under review 1 |
| Ethics approval |
1. The Institutional Review Board, McGill University, Canada, 13 December 2011 ref: A12-M93-09B
2. Health Canada - Natural Health Products Directorate, 18 July 2011 ref: 169160 |
| Study design | Randomized controlled trial |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Human papillomavirus infection |
| Participants - inclusion criteria |
1. Female 18-24 living in Montreal
2. Plan to remain in Montreal for at least the next year 3. Have had vaginal sex with a male partner during the last 30 days and expect that they will do so again in the next month, regardless of whether or not the male partner(s) will change 4. Not currently in a relationship that has lasted longer than 3 months 5. Be willing to follow study instructions 6. Understand French or English 7. Be willing to comply with follow-up for at least 12 months 8. Have an intact uterus 9. Have no history of cervical lesions/cancer or genital warts 10. Not previously vaccinated against HPV 11. Not be pregnant or planning to immediately become pregnant and not currently breast-feeding 12. Not had a recent (within the last 6 weeks) pregnancy, abortion, or genital surgery 13. Be using a medically acceptable method of contraception and intend to use it for the duration of the trial 14. Have no HIV infection 15. Have no known allergy or hypersensitivity to vaginal lubricants 16. Have no allergy to all of the ingredients of the study product or placebo |
| Participants - exclusion criteria | Does not meet inclusion criteria |
| Anticipated start date | 15/04/2012 |
| Anticipated end date | 15/04/2016 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 465 |
| Interventions |
Intervention: Treatment with carrageenan-containing vaginal gel, self-applied every other day (whether or not participants have intercourse) for the first month and prior to each act of vaginal or anal intercourse during the entire follow up period (1 year).
Control: Treatment with placebo vaginal gel, self-applied every other day (whether or not participants have intercourse) for the first month and prior to each act of vaginal or anal intercourse during the entire follow up period (1 year). Prior to vaginal intercourse, participants will be asked to apply the study gel either directly inside their vagina and externally on the genitals. During intercourse, additional lubricant can be applied as desired. During the first month, participants will be asked to apply the gel both inside their vagina, as well as on to their genitals every other regardless of whether or not they have intercourse. Study participants will be asked to continue using the assigned intervention for the complete follow up period (1 year) along with any other methods of contraception and/or sexually tansmitted infection (STI) prevention (e.g., condoms). |
| Primary outcome measure(s) |
1. Reduction in HPV incidence
2. Presence of: 2.1. A newly detected vaginal infection in someone who was HPV negative at enrolment or 2.2. HPV types other than those observed at enrolment 3. Clearance of infections with HPV types observed at baseline. HPV DNA detection and genotyping of vaginal samples will be done by the PGMY polymerase chain reaction protocol. HPV infection status will be measured at baseline (enrolment/ time 0), 14 days and 1, 3, 6, 9 and 12 months after enrolment. |
| Secondary outcome measure(s) |
Reduction in HPV prevalence (i.e., clearance of infections with HPV types observed at baseline).
HPV DNA detection and genotyping of vaginal samples will be done by the PGMY polymerase chain reaction protocol. HPV infection status will be measured at baseline (enrolment/ time 0), 14 days and 1, 3, 6, 9 and 12 months after enrolment. |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) |
| Trial website | http://www.mcgill.ca/catch |
| Publications | |
| Contact name | Dr Eduardo Franco |
| Address |
McGill University
Division of Cancer Epidemiology 546, Pine Avenue West |
| City/town | Montreal |
| Zip/Postcode | H2W 1S6 |
| Country | Canada |
| Tel | +1 514 398 8014 |
| Fax | +1 514 398 5002 |
| eduardo.franco@mcgill.ca | |
| Sponsor | Canadian Institutes of Health Research (CIHR) (Canada) |
| Address | 160 Elgin Street |
| City/town | Ottawa |
| Zip/Postcode | K1A 0W9 |
| Country | Canada |
| Tel | +1 613 941 2672 |
| Fax | +1 613 954 1800 |
| info@cihr-irsc.gc.ca | |
| Sponsor website: | http://www.cihr-irsc.gc.ca/e/193.html |
| Date applied | 10/02/2012 |
| Last edited | 07/03/2012 |
| Date ISRCTN assigned | 07/03/2012 |
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| © 2013 ISRCTN unless otherwise stated. | |
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