A Trial to Compare Antibacterial vs. Placebo Mouthwash to Reduce the Incidence of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men (MSM) Taking HIV Pre-Exposure Prophylaxis (PrEP)
NCT03881007 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 343
Last updated 2021-05-07
Summary
The study involves a randomized placebo controlled trial that aims to assess if a mouthwash (Listerine cool mint, LCM) is able to reduce the cumulative incidence of gonorrhoea (Ng), chlamydia (Ct) and syphilis in men who have sex with men and receiving preexposure prophylaxis (PrEP) at the Institute of Tropical Medicine (ITM).
Conditions
- Sexually Transmitted Diseases
Interventions
- OTHER
-
Mouthwash with LCM
Subjects will mouthwash daily with LCM and before/after sex
- OTHER
-
Mouthwash with placebo
Subjects will mouthwash daily with placebo and before/after sex
Sponsors & Collaborators
-
Institute of Tropical Medicine, Belgium
lead OTHER
Principal Investigators
-
Chris Kenyon, MD · Institute of Tropical Medicine Antwerp
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-04-03
- Primary Completion
- 2020-06-15
- Completion
- 2020-06-15
Countries
- Belgium
Study Locations
More Related Trials
-
Rectal Safety and Acceptability Study of Tenofovir 1% Gel
NCT01232803 ·Status: COMPLETED ·Phase: PHASE1
-
Griffithsin-based Rectal Microbicide for PREvention of Viral ENTry (PREVENT)
NCT04032717 ·Status: TERMINATED ·Phase: PHASE1
-
SPL7013 Gel - Male Tolerance Study
NCT00370357 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Acceptability and Preliminary Effectiveness of PC-515 for Vaginal Use as a Possible Microbicide
NCT00213031 ·Status: COMPLETED ·Phase: PHASE2
-
Doxycycline Prophylaxis for Prevention of Sexually Transmitted Infections
NCT06738407 ·Status: RECRUITING ·Phase: PHASE4
-
Randomised Controlled Trial of Condoms Plus Additional Lubrication
NCT00369213 ·Status: COMPLETED ·Phase: PHASE4
-
Spermicidal Efficacy Of A Vaginal Gel
NCT03833115 ·Status: COMPLETED ·Phase: NA
-
Brief Intervention and/or Distribution of Free Condoms for Travelers
NCT01056536 ·Status: COMPLETED ·Phase: NA
-
Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection
NCT04553068 ·Status: COMPLETED ·Phase: PHASE3
-
Interventional Study of Mucosal and Antimicrobial Responses to Repeated Vaginal Applications of Tenofovir Gel in HIV Uninfected Women
NCT00594373 ·Status: COMPLETED ·Phase: PHASE1
-
Condom Performance in a Longitudinal Enhanced Assessment of User Experiences
NCT02753842 ·Status: COMPLETED ·Phase: NA
-
Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom
NCT05912283 ·Status: COMPLETED ·Phase: NA
-
Safety and Acceptability of SPL7013 Gel (VivaGel™) in Sexually Active Women
NCT00442910 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety and Acceptability Study of a Vaginal Ring Microbicide Delivery Method
NCT00469170 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
A Clinical Feasibility Study to Assess the Performance of a Latex Condom in Healthy Monogamous Couples.
NCT05073770 ·Status: UNKNOWN ·Phase: NA
-
Safety and Acceptability Study of the UC-781 Microbicide Gel Applied Rectally
NCT00408538 ·Status: COMPLETED ·Phase: PHASE1
-
62% & 15% Ethanol in Emollient Gel as Topical Male Microbicides
NCT00469547 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Acceptability of Carraguard™ Among HIV-negative Couples in Thailand
NCT00213057 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Acceptability of a Vaginal Microbicide
NCT00111943 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of BufferGel in Women
NCT00000927 ·Status: COMPLETED ·Phase: PHASE1
-
Safety Study of UC-781 Vaginal Microbicide
NCT00446979 ·Status: COMPLETED ·Phase: PHASE1
-
Study of UC-781 Vaginal Microbicide
NCT00132444 ·Status: COMPLETED ·Phase: PHASE1
-
Synthetic Male Condom Slippage-Breakage Study
NCT05370196 ·Status: COMPLETED ·Phase: NA
-
Study to Evaluate the Safety of Griffithsin in a Carrageenan Gel in Healthy Women
NCT02875119 ·Status: COMPLETED ·Phase: PHASE1
-
Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection
NCT00262106 ·Status: COMPLETED ·Phase: PHASE3