Trial Outcomes & Findings for Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (NCT NCT02354144)
NCT ID: NCT02354144
Last Updated: 2021-06-15
Results Overview
Detection of 36 different HPV types will allow for the assessment of new HPV types even among those already infected.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
258 participants
Primary outcome timeframe
One year follow-up
Results posted on
2021-06-15
Participant Flow
Recruitment for the LIMIT-HPV trial began in February 2016 at the following sites in Montreal, Canada: McGill University Health Centre, Clinique Médicale Urbaine du Quartier-Latin, Clinique OPUS, and two student health services clinics (McGill and Concordia universities). From September 2018 to March 2020, study visits were completed at McGill University's Division of Cancer Epidemiology's research clinic. 255 of the 258 participants were enrolled and analyzed at the time of interim analysis.
Participant milestones
| Measure |
Carrageenan-based Gel
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.
Carrageenan-based gel: Carrageenan is a non-toxic gelling agent safe in animals and humans as a potent HPV inhibitor. An anionic polymer derived from red algae, carrageenan has a long history of human use as a stabilizer and emulsifier in many industries. All three major classes of carrageenan act as extremely potent HPV inhibitors and block HPV infection by binding to the viral capsid, thus preventing attachment to the appropriate cell-surface heparan sulfate proteoglycans (HSPG) receptors.
|
Control Gel
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.
Control gel: A gel not containing carrageenan
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
128
|
|
Overall Study
COMPLETED
|
48
|
51
|
|
Overall Study
NOT COMPLETED
|
79
|
77
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lubricant Investigation in Men to Inhibit Transmission of HPV Infection
Baseline characteristics by cohort
| Measure |
Carrageenan-based Gel
n=127 Participants
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.
Carrageenan-based gel: Carrageenan is a non-toxic gelling agent safe in animals and humans as a potent HPV inhibitor. An anionic polymer derived from red algae, carrageenan has a long history of human use as a stabilizer and emulsifier in many industries. All three major classes of carrageenan act as extremely potent HPV inhibitors and block HPV infection by binding to the viral capsid, thus preventing attachment to the appropriate cell-surface heparan sulfate proteoglycans (HSPG) receptors.
|
Control Gel
n=128 Participants
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.
Control gel: A gel not containing carrageenan
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
36.9 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
French Canadian
|
48 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
English Canadian
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latin American
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
European
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Human immunodeficiency virus status, positive
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
HPV DNA status
|
84 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One year follow-upPopulation: 201 participants were included in the intention to treat analyses. Of the 255 initially randomized, 45 were excluded because they only had one visit and 9 were excluded because HPV data was unavailable.
Detection of 36 different HPV types will allow for the assessment of new HPV types even among those already infected.
Outcome measures
| Measure |
Carrageenan-based Gel
n=98 Participants
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.
Carrageenan-based gel: Carrageenan is a non-toxic gelling agent safe in animals and humans as a potent HPV inhibitor. An anionic polymer derived from red algae, carrageenan has a long history of human use as a stabilizer and emulsifier in many industries. All three major classes of carrageenan act as extremely potent HPV inhibitors and block HPV infection by binding to the viral capsid, thus preventing attachment to the appropriate cell-surface heparan sulfate proteoglycans (HSPG) receptors.
|
Control Gel
n=103 Participants
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.
Control gel: A gel not containing carrageenan
|
|---|---|---|
|
Presence of a Newly Detected Anal Infection of a Specific HPV Type in a Man Who Was Negative for That HPV Type at Enrollment
|
68 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: One year follow-upPopulation: Of the 255 participants randomized at the time of interim analysis, there were 134 participants positive for HPV at baseline that had at least 2 visits with valid HPV results. These 134 participants were included in the clearance analyses.
Detection of 36 different HPV types will allow for the assessment of clearance of any HPV type or specific HPV types.
Outcome measures
| Measure |
Carrageenan-based Gel
n=68 Participants
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.
Carrageenan-based gel: Carrageenan is a non-toxic gelling agent safe in animals and humans as a potent HPV inhibitor. An anionic polymer derived from red algae, carrageenan has a long history of human use as a stabilizer and emulsifier in many industries. All three major classes of carrageenan act as extremely potent HPV inhibitors and block HPV infection by binding to the viral capsid, thus preventing attachment to the appropriate cell-surface heparan sulfate proteoglycans (HSPG) receptors.
|
Control Gel
n=66 Participants
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.
Control gel: A gel not containing carrageenan
|
|---|---|---|
|
Clearance of Anal Type-specific HPV Infections Found at Baseline
|
19 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: One year follow-upPopulation: Of the 255 participants randomized at the time of interim analysis, 210 participants had available follow-up and were included in adherence and safety analyses.
Measured via questionnaires and review of patient adverse event reports. Adherence was defined as the number of times the gel was used during receptive anal intercourse divided by the number of receptive anal intercourse in the 7 days preceding each visit. Participants were considered adherent at a particular visit if they used the gel during receptive anal intercourse ≥ 50% of the time. This variable was analyzed at the visit level. Safety analyses are included in the adverse event reporting section.
Outcome measures
| Measure |
Carrageenan-based Gel
n=428 visits
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.
Carrageenan-based gel: Carrageenan is a non-toxic gelling agent safe in animals and humans as a potent HPV inhibitor. An anionic polymer derived from red algae, carrageenan has a long history of human use as a stabilizer and emulsifier in many industries. All three major classes of carrageenan act as extremely potent HPV inhibitors and block HPV infection by binding to the viral capsid, thus preventing attachment to the appropriate cell-surface heparan sulfate proteoglycans (HSPG) receptors.
|
Control Gel
n=441 visits
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.
Control gel: A gel not containing carrageenan
|
|---|---|---|
|
Patient Adherence, Measured Via Questionnaires and Review of Patient Adverse Event Reports.
|
361 visits
|
389 visits
|
Adverse Events
Carrageenan-based Gel
Serious events: 0 serious events
Other events: 61 other events
Deaths: 0 deaths
Control Gel
Serious events: 1 serious events
Other events: 43 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Carrageenan-based Gel
n=102 participants at risk
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.
Carrageenan-based gel: Carrageenan is a non-toxic gelling agent safe in animals and humans as a potent HPV inhibitor. An anionic polymer derived from red algae, carrageenan has a long history of human use as a stabilizer and emulsifier in many industries. All three major classes of carrageenan act as extremely potent HPV inhibitors and block HPV infection by binding to the viral capsid, thus preventing attachment to the appropriate cell-surface heparan sulfate proteoglycans (HSPG) receptors.
|
Control Gel
n=108 participants at risk
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.
Control gel: A gel not containing carrageenan
|
|---|---|---|
|
Infections and infestations
Death
|
0.00%
0/102 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
0.93%
1/108 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
Other adverse events
| Measure |
Carrageenan-based Gel
n=102 participants at risk
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.
Carrageenan-based gel: Carrageenan is a non-toxic gelling agent safe in animals and humans as a potent HPV inhibitor. An anionic polymer derived from red algae, carrageenan has a long history of human use as a stabilizer and emulsifier in many industries. All three major classes of carrageenan act as extremely potent HPV inhibitors and block HPV infection by binding to the viral capsid, thus preventing attachment to the appropriate cell-surface heparan sulfate proteoglycans (HSPG) receptors.
|
Control Gel
n=108 participants at risk
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.
Control gel: A gel not containing carrageenan
|
|---|---|---|
|
Product Issues
Unusual pain during anal sex
|
5.3%
4/75 • Number of events 4 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
0.00%
0/77 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Rectal bleeding in between anal sex
|
8.0%
6/75 • Number of events 6 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
0.00%
0/77 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Unusual abdominal pain
|
2.7%
2/75 • Number of events 2 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
0.00%
0/77 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Unusually painful defecation
|
0.00%
0/75 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
0.00%
0/77 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Flatulence, constipation, urgency and/or fecal incontinence or diarrhea
|
0.00%
0/75 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
1.3%
1/77 • Number of events 1 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Rectal abscess/ulcer/fistulae
|
0.00%
0/75 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
0.00%
0/77 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Anal discharge
|
2.7%
2/75 • Number of events 2 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
0.00%
0/77 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Hemorrhoids
|
10.8%
11/102 • Number of events 11 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
6.5%
7/108 • Number of events 7 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Itching, burning, edema or pain in the anorectal area
|
5.3%
4/75 • Number of events 4 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
0.00%
0/77 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Anal fissures
|
0.00%
0/75 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
0.00%
0/77 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Other
|
4.0%
3/75 • Number of events 3 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
1.3%
1/77 • Number of events 1 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Use of the gel caused discomfort/adverse reactions to you
|
18.2%
18/99 • Number of events 18 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
7.8%
8/103 • Number of events 8 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Use of the gel caused discomfort/adverse reactions to your partner(s)
|
13.1%
13/99 • Number of events 13 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
1.9%
2/105 • Number of events 2 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Reported bleeding following receptive anal intercourse
|
49.5%
47/95 • Number of events 47 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
42.6%
43/101 • Number of events 43 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Warts
|
5.9%
6/102 • Number of events 6 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
6.5%
7/108 • Number of events 7 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Erythema
|
5.9%
6/102 • Number of events 6 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
8.3%
9/108 • Number of events 9 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Abrasions
|
3.9%
4/102 • Number of events 4 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
1.9%
2/108 • Number of events 2 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Inflammation
|
2.0%
2/102 • Number of events 2 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
0.00%
0/108 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Fissures
|
2.9%
3/102 • Number of events 3 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
1.9%
2/108 • Number of events 2 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Abscesses
|
0.98%
1/102 • Number of events 1 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
0.93%
1/108 • Number of events 1 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Venereal warts or condylomas
|
2.1%
2/95 • Number of events 2 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
3.3%
3/92 • Number of events 3 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Chlamydia
|
13.7%
14/102 • Number of events 14 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
11.1%
12/108 • Number of events 12 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Lymphogranuloma vereneum
|
0.00%
0/102 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
0.93%
1/108 • Number of events 1 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Anal or genital herpes
|
4.9%
5/102 • Number of events 5 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
4.6%
5/108 • Number of events 5 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Syphilis
|
6.9%
7/102 • Number of events 7 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
6.5%
7/108 • Number of events 7 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Gonorrhea
|
22.5%
23/102 • Number of events 23 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
9.3%
10/108 • Number of events 10 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Ulcers or genital sores
|
0.00%
0/102 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
0.93%
1/108 • Number of events 1 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Hepatitis B
|
0.00%
0/102 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
0.93%
1/108 • Number of events 1 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Hepatitis C
|
0.00%
0/102 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
1.9%
2/108 • Number of events 2 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
HIV
|
0.98%
1/102 • Number of events 1 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
0.00%
0/108 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Anal precancer
|
0.00%
0/102 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
0.93%
1/108 • Number of events 1 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
|
Product Issues
Cancer
|
0.00%
0/102 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
0.93%
1/108 • Number of events 1 • Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
|
Additional Information
Dr. Eduardo Franco
Division of Cancer Epidemiology, Department of Oncology, McGill University
Phone: 514-398-6032
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place