Trial Outcomes & Findings for Condom Performance in a Longitudinal Enhanced Assessment of User Experiences (NCT NCT02753842)
NCT ID: NCT02753842
Last Updated: 2020-08-25
Results Overview
Our aim was to compare fitted condoms with standard condoms regarding levels of reported pleasure, as determined by rating per condom use event. The sexual pleasure scale for this study was developed and validated by the study team (Siegler et. al., Arch Sex Behav. 2018 Aug; 47(6): 1745-1754), and is titled event-level, male sexual pleasure scale (EMSEXpleasure). The scale comprises 11 items with sliding scale response scores. Pleasure scale measurement was assessed with a mobile-optimized, web-based home daily coital log, completed following each coital event. The minimum scale score was zero, the maximum was 100. Higher values indicate greater pleasure. We assessed the difference in mean scores of pleasure for fitted condoms versus standard condoms.
COMPLETED
NA
504 participants
Up to 12 weeks
2020-08-25
Participant Flow
Participants were recruited in Atlanta, GA from May 19, 2016 - May 2, 2017. Recruitment was predominantly through electronic advertising and paper signs posted at venues such as college campuses.
We recruited 504 participants into the crossover trial. Participants were randomized into one of six sequences, each representing the order in which a participant would receive batches of five study condoms of a particular type.
Participant milestones
| Measure |
Fitted, Then Thin, Then Standard Condoms
Participants first received 5 fitted condoms, and had a period of 2-4 weeks to use them. They then received 5 thin condoms, and had a period of 2-4 weeks to use them. They then received 5 standard condoms, and had a period of 2-4 weeks to use them.
|
Fitted, Then Standard, Then Thin Condoms
Participants first received 5 fitted condoms, and had a period of 2-4 weeks to use them. They then received 5 standard condoms, and had a period of 2-4 weeks to use them. They then received 5 thin condoms, and had a period of 2-4 weeks to use them.
|
Thin, Then Fitted, Then Standard Condoms
Participants first received 5 thin condoms, and had a period of 2-4 weeks to use them. They then received 5 fitted condoms, and had a period of 2-4 weeks to use them. They then received 5 standard condoms, and had a period of 2-4 weeks to use them.
|
Thin, Then Standard, Then Fitted Condoms
Participants first received 5 thin condoms, and had a period of 2-4 weeks to use them. They then received 5 standard condoms, and had a period of 2-4 weeks to use them. They then received 5 fitted condoms, and had a period of 2-4 weeks to use them.
|
Standard, Then Fitted, Then Thin Condoms
Participants first received 5 standard condoms, and had a period of 2-4 weeks to use them. They then received 5 fitted condoms, and had a period of 2-4 weeks to use them. They then received 5 thin condoms, and had a period of 2-4 weeks to use them.
|
Standard, Then Thin, Then Fitted Condoms
Participants first received 5 standard condoms, and had a period of 2-4 weeks to use them. They then received 5 thin condoms, and had a period of 2-4 weeks to use them. They then received 5 fitted condoms, and had a period of 2-4 weeks to use them.
|
|---|---|---|---|---|---|---|
|
First Follow-Up (Set of Condoms)
STARTED
|
85
|
84
|
85
|
83
|
83
|
84
|
|
First Follow-Up (Set of Condoms)
COMPLETED
|
75
|
76
|
76
|
81
|
76
|
79
|
|
First Follow-Up (Set of Condoms)
NOT COMPLETED
|
10
|
8
|
9
|
2
|
7
|
5
|
|
Second Follow-Up (Set of Condoms)
STARTED
|
75
|
76
|
76
|
81
|
76
|
79
|
|
Second Follow-Up (Set of Condoms)
COMPLETED
|
71
|
71
|
71
|
76
|
75
|
72
|
|
Second Follow-Up (Set of Condoms)
NOT COMPLETED
|
4
|
5
|
5
|
5
|
1
|
7
|
|
Third Follow-Up (Set of Condoms)
STARTED
|
71
|
71
|
71
|
76
|
75
|
72
|
|
Third Follow-Up (Set of Condoms)
COMPLETED
|
65
|
66
|
68
|
70
|
71
|
69
|
|
Third Follow-Up (Set of Condoms)
NOT COMPLETED
|
6
|
5
|
3
|
6
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Condom Performance in a Longitudinal Enhanced Assessment of User Experiences
Baseline characteristics by cohort
| Measure |
Fitted, Then Thin, Then Standard Condoms
n=85 Participants
Fitted, Then Thin, Then Standard Condoms.
|
Fitted, Then Standard, Then Thin Condoms
n=84 Participants
Fitted, Then Standard, Then Thin Condoms.
|
Thin, Then Fitted, Then Standard Condoms
n=85 Participants
Thin, Then Fitted, Then Standard Condoms.
|
Thin, Then Standard, Then Fitted Condoms
n=83 Participants
Thin, Then Standard, Then Fitted Condoms.
|
Standard, Then Fitted, Then Thin Condoms
n=83 Participants
Standard, Then Fitted, Then Thin Condoms.
|
Standard, Then Thin, Then Fitted Condoms
n=84 Participants
Standard, Then Thin, Then Fitted Condoms.
|
Total
n=504 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
< 20 years
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
8 Participants
n=157 Participants
|
15 Participants
n=390 Participants
|
4 Participants
n=16 Participants
|
56 Participants
n=3 Participants
|
|
Age, Customized
20-24 years
|
28 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
29 Participants
n=157 Participants
|
21 Participants
n=390 Participants
|
26 Participants
n=16 Participants
|
158 Participants
n=3 Participants
|
|
Age, Customized
25-29 years
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
20 Participants
n=157 Participants
|
24 Participants
n=390 Participants
|
22 Participants
n=16 Participants
|
123 Participants
n=3 Participants
|
|
Age, Customized
30-39 years
|
23 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
19 Participants
n=157 Participants
|
15 Participants
n=390 Participants
|
15 Participants
n=16 Participants
|
108 Participants
n=3 Participants
|
|
Age, Customized
40-54 years
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
7 Participants
n=157 Participants
|
8 Participants
n=390 Participants
|
17 Participants
n=16 Participants
|
59 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
83 Participants
n=157 Participants
|
83 Participants
n=390 Participants
|
84 Participants
n=16 Participants
|
504 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
7 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
11 Participants
n=157 Participants
|
6 Participants
n=390 Participants
|
13 Participants
n=16 Participants
|
62 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
White non-Hispanic
|
45 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
32 Participants
n=157 Participants
|
40 Participants
n=390 Participants
|
40 Participants
n=16 Participants
|
241 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
African-American non-Hispanic
|
18 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
25 Participants
n=157 Participants
|
23 Participants
n=390 Participants
|
23 Participants
n=16 Participants
|
131 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Other non-Hispanic
|
15 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
14 Participants
n=157 Participants
|
14 Participants
n=390 Participants
|
8 Participants
n=16 Participants
|
69 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Prefer not to answer, non-Hispanic
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=99 Participants
|
84 participants
n=107 Participants
|
85 participants
n=206 Participants
|
83 participants
n=157 Participants
|
83 participants
n=390 Participants
|
84 participants
n=16 Participants
|
504 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: The analysis is comprised of pleasure scale scores completed after each sex act, when a study condom was used.
Our aim was to compare fitted condoms with standard condoms regarding levels of reported pleasure, as determined by rating per condom use event. The sexual pleasure scale for this study was developed and validated by the study team (Siegler et. al., Arch Sex Behav. 2018 Aug; 47(6): 1745-1754), and is titled event-level, male sexual pleasure scale (EMSEXpleasure). The scale comprises 11 items with sliding scale response scores. Pleasure scale measurement was assessed with a mobile-optimized, web-based home daily coital log, completed following each coital event. The minimum scale score was zero, the maximum was 100. Higher values indicate greater pleasure. We assessed the difference in mean scores of pleasure for fitted condoms versus standard condoms.
Outcome measures
| Measure |
Fitted Condoms
n=4740 Sex acts with study condoms
Participants received all conditions (fitted condoms, thin condoms, and standard condoms), with the order in which condoms are received based on permuted block randomization.
|
Standard Condoms
n=4740 Sex acts with study condoms
Participants will receive all conditions (fitted condoms, thin condoms, and standard condoms), with the order in which condoms are received based on permuted block randomization.
|
Standard Condoms
Standard condoms used for anal sex
|
|---|---|---|---|
|
Sexual Pleasure Scale Score for Fitted Versus Standard Condoms
|
71.52 score on a scale
Standard Error 0.77
|
70.13 score on a scale
Standard Error 0.78
|
—
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Participants who used at least one fitted and one standard condom
Our aim was to compare fitted condoms with standard condoms regarding preference, as determined by ranking of the two conditions at the study conclusion. Condom preference was determined by participants selecting a preference for fitted or standard condoms at the study conclusion. The measure used assessed a blinded preference, referring to the color assigned to the condom type rather than the type of condom by name.
Outcome measures
| Measure |
Fitted Condoms
n=371 Participants
Participants received all conditions (fitted condoms, thin condoms, and standard condoms), with the order in which condoms are received based on permuted block randomization.
|
Standard Condoms
Participants will receive all conditions (fitted condoms, thin condoms, and standard condoms), with the order in which condoms are received based on permuted block randomization.
|
Standard Condoms
Standard condoms used for anal sex
|
|---|---|---|---|
|
Percent of Participants Preferring Fitted Condoms to Standard Condoms
|
53.0 % of participants prefer fitted condoms
Interval 47.9 to 58.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Participants who used at least one condom during the study
Our aim was to assess for fitted, thin, and standard condoms the total clinical failure rate of each type of condom for anal sex among MSM relative to the 5% failure cut-point previously used by the United States Food and Drug Administration (FDA). Clinical condom failure (condom breakage and slippage) was assessed by questions from the International Organization for Standardization (ISO), with a mobile-optimized, web-based home daily coital log completed following each coital event. Clinical failure was calculated according to ISO guidance.
Outcome measures
| Measure |
Fitted Condoms
n=813 Condoms
Participants received all conditions (fitted condoms, thin condoms, and standard condoms), with the order in which condoms are received based on permuted block randomization.
|
Standard Condoms
n=788 Condoms
Participants will receive all conditions (fitted condoms, thin condoms, and standard condoms), with the order in which condoms are received based on permuted block randomization.
|
Standard Condoms
n=750 Condoms
Standard condoms used for anal sex
|
|---|---|---|---|
|
Clinical Condom Failure for Anal Sex
|
5 Condoms
|
6 Condoms
|
5 Condoms
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Persons contributing data regarding performance of at least one condom in the condition.
Our aim was to compare fitted condoms with standard condoms regarding total clinical failure for anal sex among MSM. Clinical condom failure (condom breakage and slippage) was assessed based on questions suggested by the International Organization for Standardization (ISO) and with a mobile-optimized, web-based home daily coital log completed following each coital event. Clinical failure was calculated according to ISO guidance.
Outcome measures
| Measure |
Fitted Condoms
n=813 Condoms
Participants received all conditions (fitted condoms, thin condoms, and standard condoms), with the order in which condoms are received based on permuted block randomization.
|
Standard Condoms
n=750 Condoms
Participants will receive all conditions (fitted condoms, thin condoms, and standard condoms), with the order in which condoms are received based on permuted block randomization.
|
Standard Condoms
Standard condoms used for anal sex
|
|---|---|---|---|
|
Clinical Condom Failure of Fitted Condoms Compared to Standard Condoms for Anal Sex
|
5 Condoms
|
5 Condoms
|
—
|
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: The analysis is comprised of pleasure scale scores completed after each sex act, when a study condom was used.
This secondary outcome sought to compare thin condoms with standard condoms regarding levels of reported pleasure, as determined by rating per condom use event. The sexual pleasure scale for this study was developed and validated by the study team (Siegler et. al., Arch Sex Behav. 2018 Aug; 47(6): 1745-1754), and is titled event-level, male sexual pleasure scale (EMSEXpleasure). The scale comprises 11 items with sliding scale response scores. Pleasure scale measurement was assessed with a mobile-optimized, web-based home daily coital log, completed following each coital event. The minimum scale score was zero, the maximum was 100. Higher values indicate greater pleasure. We assessed the difference in mean scores of pleasure for thin condoms versus standard condoms.
Outcome measures
| Measure |
Fitted Condoms
n=4740 Sex acts with study condoms
Participants received all conditions (fitted condoms, thin condoms, and standard condoms), with the order in which condoms are received based on permuted block randomization.
|
Standard Condoms
n=4740 Sex acts with study condoms
Participants will receive all conditions (fitted condoms, thin condoms, and standard condoms), with the order in which condoms are received based on permuted block randomization.
|
Standard Condoms
Standard condoms used for anal sex
|
|---|---|---|---|
|
Sexual Pleasure Scale Score for Thin Versus Standard Condoms
|
71.19 score on a scale
Standard Error 0.77
|
70.13 score on a scale
Standard Error 0.78
|
—
|
Adverse Events
Fitted Condoms
Thin Condoms
Standard Condoms
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fitted Condoms
n=468 participants at risk
Fitted condoms are available in 56 sizes based on combinations of length (approximately 10mm increments) and circumference (approximately 2 mm increments). Fitted condom thickness is 70 microns ± 10 microns. Appropriate condom size is user-determined with a paper template fitting tool graduated with non- sequential numbering and lettering for maximum privacy. Participants also received ten plain foil packets of 10ml commercially available condom-compatible water-based lubricant.
|
Thin Condoms
n=469 participants at risk
Thin condoms have dimensions of 185mm ± 10mm length, 53mm ± 2mm width, and 50 microns ± 5 microns thick. Participants also received ten plain foil packets of 10ml commercially available condom-compatible water-based lubricant.
|
Standard Condoms
n=464 participants at risk
Standard condoms have dimensions of 185mm ± 10mm length, 53mm ± 2mm width, and 70 microns ± 10 microns thick. Participants also received ten plain foil packets of 10ml commercially available condom-compatible water-based lubricant.
|
|---|---|---|---|
|
Investigations
Symptomatic STI or recent STI diagnosis
|
0.64%
3/468 • Number of events 3 • The period of study participation, ranging from 0-12 weeks.
We used standard definitions for adverse events
|
0.85%
4/469 • Number of events 4 • The period of study participation, ranging from 0-12 weeks.
We used standard definitions for adverse events
|
0.43%
2/464 • Number of events 2 • The period of study participation, ranging from 0-12 weeks.
We used standard definitions for adverse events
|
|
Investigations
Condom- or lube-related discomfort
|
0.85%
4/468 • Number of events 4 • The period of study participation, ranging from 0-12 weeks.
We used standard definitions for adverse events
|
1.5%
7/469 • Number of events 7 • The period of study participation, ranging from 0-12 weeks.
We used standard definitions for adverse events
|
0.86%
4/464 • Number of events 4 • The period of study participation, ranging from 0-12 weeks.
We used standard definitions for adverse events
|
|
Investigations
Partner discomfort with lubricant
|
0.21%
1/468 • Number of events 1 • The period of study participation, ranging from 0-12 weeks.
We used standard definitions for adverse events
|
0.00%
0/469 • The period of study participation, ranging from 0-12 weeks.
We used standard definitions for adverse events
|
0.00%
0/464 • The period of study participation, ranging from 0-12 weeks.
We used standard definitions for adverse events
|
|
Investigations
Partner Urinary Tract Infection
|
0.21%
1/468 • Number of events 1 • The period of study participation, ranging from 0-12 weeks.
We used standard definitions for adverse events
|
0.00%
0/469 • The period of study participation, ranging from 0-12 weeks.
We used standard definitions for adverse events
|
0.00%
0/464 • The period of study participation, ranging from 0-12 weeks.
We used standard definitions for adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place