Clinical trial · Interventional
Lubricant Investigation in Men to Inhibit Transmission of HPV Infection
A Randomized Controlled Trial of a Carrageenan-Containing Lubricant to Reduce Transmission of Human Papillomavirus Infection Among Men Who Have Sex With Men
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Mandated by DSMB
Summary
Brief summary (as posted)
The LIMIT-Study is a placebo-controlled, double-blinded randomized controlled trial designed to explore the efficacy of a carrageenan-based lubricant as a topical microbicide for preventing HPV acquisition. Individuals at high risk for infection (men who have sex with men, or MSM, and especially those with HIV) will be included in the trial. Participants will complete a self-administered baseline questionnaire during the enrollment visit, and follow-up questionnaires during all other six visits. The shorter follow-up questionnaires are intended to evaluate recent sexual behaviours and to corroborate the responses given during the baseline visit. These questionnaires will measure HPV risk factors, compliance, and monitor safety and tolerability of the gels. Between follow-up visits, participants will be asked to log into a secure web module at least once a week to answer questions on daily sexual activities, condom and study gel use, and adverse events. Individuals will be screened for eligibility over the telephone or in person and eligible men will attend an enrollment visit, where the nurse will obtain informed consent and instruct the participant on gel use. They will receive a one month's supply of gel and provide the first specimen. Random number sets will be assigned to the treatment and control gel. Each participant will be assigned an individual code, which will be used to match him to the study arm. Lastly, the nurse will provide details about HPV infection and advice about condom use and sexual health. HPV infection status will be measured using anal specimens at baseline (enrollment/time 0), and at all follow-up clinic visits (1, 2, 3, 6, 9 and 12 months).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carrageenan-based gel | Other | — | UNRESOLVED |
| Control gel | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Carrageenan-based gel
- description
- The intervention to be administered is: * a commercially available gel that contains carrageenan. * water-based, latex-condom compatible, clear, odourless, tasteless, and have similar viscosity as the placebo gel. * also packaged in a similar plastic bottle with a disk cap that can be operated with one finger, and must be applied prior to anal intercourse during the entire study period. Around 15 ml of the personal lubricant will be dispensed into the hand and applied directly to the genital, anal, and condom surfaces prior to and as needed during anal sex. When sexual activity ceases, the water-based formulation of the gel allows it to be easily removed with lukewarm water.
- interventionNames
- Other: Carrageenan-based gel
- type
- PLACEBO_COMPARATOR
- label
- Control gel
- description
- The intervention to be administered is: * a commercially available gel that does not contain carrageenan. * water-based, latex-condom compatible, clear, odourless, tasteless, and have similar viscosity as the carrageenan-containing gel. * also packaged in a similar plastic bottle with a disk cap that can be operated with one finger, and must be applied prior to anal intercourse during the entire study period. Around 15 ml of the personal lubricant will be dispensed into the hand and applied directly to the genital, anal, and condom surfaces prior to and as needed during anal sex. When sexual activity ceases, the water-based formulation of the gel allows it to be easily removed with lukewarm water.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men aged 18 or older, * Men living in Montreal and plan to remain in the city for the next 12 months, * Men who have had receptive anal sex with one or more men during the previous 3 months and intend to continue being sexually active for the duration of their involvement in the study, irrespective of whether their sexual partner will change, * Men planning on having receptive anal sex with two or more men, but less than 50 DIFFERENT partners per year * Men who understands French or English, * Men willing to follow study instructions and comply with follow-ups for 12 months. Exclusion Criteria: * Men must not be receiving treatment for anal or perianal condylomas or anal intraepithelial neoplasia lesions during the trial, * Men must not have a known allergy or hypersensitivity to any of the ingredients in either gels.
References
Publications (4)
- DERIVEDKassam P, El-Zein M, Tota JE, Tellier PP, Coutlee F, de Pokomandy A, Franco EL. HPV vaccination and anal HPV infection in gay, bisexual, and other men who have sex with men. Vaccine. 2025 Jan 25;45:126644. doi: 10.1016/j.vaccine.2024.126644. Epub 2024 Dec 21. PMID 39708517
- DERIVEDLaurie C, El-Zein M, Tota J, Khosrow-Khavar F, Tellier PP, Coutlee F, de Pokomandy A, Franco EL; Lubricant Investigation in Men to Inhibit Transmission of Human Papillomavirus Infection (LIMIT-HPV) Study Group. Efficacy of a Carrageenan Gel in Increasing Clearance of Anal Human Papillomavirus Infections in Men: Interim Analysis of a Double-Blind, Randomized Controlled Trial. J Infect Dis. 2023 Feb 1;227(3):402-406. doi: 10.1093/infdis/jiac019. PMID 35090175
- DERIVEDLaurie C, El-Zein M, Tota JE, Khosrow-Khavar F, Tellier PP, Coutlee F, de Pokomandy A, Franco EL; LIMIT-HPV study group. Efficacy of a carrageenan gel in preventing anal human papillomavirus (HPV) infection: interim analysis of the Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV) randomised controlled trial. Sex Transm Infect. 2022 Jun;98(4):239-246. doi: 10.1136/sextrans-2021-055009. Epub 2021 Jun 17. PMID 34140405
- DERIVEDLaurie C, El-Zein M, Tota J, Tellier PP, Coutlee F, Franco EL, de Pokomandy A; LIMIT-HPV study group. Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV): design and methods for a randomised controlled trial. BMJ Open. 2020 Mar 23;10(3):e035113. doi: 10.1136/bmjopen-2019-035113. PMID 32205376