Trial Outcomes & Findings for Developing Rectal USPE Measures (NCT NCT02102867)
NCT ID: NCT02102867
Last Updated: 2026-02-05
Results Overview
USPE Sum of averaged item means/# items (min:max 1:5); 1=Do not agree at all;2=Agree a little;3=Agree somewhat;4=Agree a lot;5=Agree completely. Products:Gel/Orange, Cream/Green, Liquid/Yellow. Initial Penetration:Smoothness/lubricity; Initial Lubrication:Coating/lubricating; Spreading Behavior:Ease of stroke, product spread; Product Awareness:Feel during sex (movement, felt betw rectal wall-penis); Perceived Wetness:Covering entire rectum, as after orgasm; Stimulating: enhanced pleasure; Messiness:Perceptions of messiness; Leakage:Sensations of leaking during/after sex, in pubic hair, cleanliness; Pre-coital Leakage:Product felt/leakage on body/clothes before sex; Naturalness:Sensation of naturalness, leakage looked like cum; Lubricity:Wetness before sex; slipperiness/lubricity during sex; Effortful:Effort needed at penetration; effort difficulty/dryness; Pleasure: Partner's stimulation; Noticeable: messiness, thickness Higher scores=greater agreement re:product characteristics
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
3 web-based surveys over an average of 6-12 weeks
Results posted on
2026-02-05
Participant Flow
Recruited (RI, MA USA) via call-lists, flyers, ads, internet/social media, clinics, CBOs, word-of-mouth.
Three female participants were withdrawn from study and did not complete product evaluation. One had a positive pregnancy, two withdrew due to not being able to follow study guidelines.
Participant milestones
| Measure |
Females
Female participants that reported user sensory perception experiences for 3 formulations (Gel, Cream, and Liquid) during Receptive Anal Intercourse (RAI).
|
Males
Male participants that reported user sensory perception experiences for 3 formulations (Gel, Cream, and Liquid) during Receptive Anal Intercourse (RAI).
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
|
Overall Study
Orange/Gel Use
|
7
|
8
|
|
Overall Study
Green/Cream Use
|
7
|
8
|
|
Overall Study
Yellow/Liquid Use
|
7
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Females
Female participants that reported user sensory perception experiences for 3 formulations (Gel, Cream, and Liquid) during Receptive Anal Intercourse (RAI).
|
Males
Male participants that reported user sensory perception experiences for 3 formulations (Gel, Cream, and Liquid) during Receptive Anal Intercourse (RAI).
|
|---|---|---|
|
Overall Study
Pregnancy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Vaginal deliveries does not apply to Male participants
Baseline characteristics by cohort
| Measure |
Females
n=7 Participants
Female participants evaluating three formulations
|
Males
n=8 Participants
Male participants evaluating three formulations
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-29 Years
|
4 Participants
n=7 Participants
|
5 Participants
n=8 Participants
|
9 Participants
n=15 Participants
|
|
Age, Customized
30+ Years
|
3 Participants
n=7 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=15 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=7 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=7 Participants
|
7 Participants
n=8 Participants
|
11 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latinx
|
0 Participants
n=7 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=15 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=7 Participants
|
8 participants
n=8 Participants
|
15 participants
n=15 Participants
|
|
Yearly Income
Less than $15,000
|
2 Participants
n=7 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=15 Participants
|
|
Yearly Income
$15,000-$36,000
|
2 Participants
n=7 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=15 Participants
|
|
Yearly Income
Mora than $36,000
|
3 Participants
n=7 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=15 Participants
|
|
History of STD Diagnosis
|
1 Participants
n=7 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=15 Participants
|
|
Vaginal Deliveries
|
3 Participants
n=7 Participants • Vaginal deliveries does not apply to Male participants
|
—
|
3 Participants
n=7 Participants • Vaginal deliveries does not apply to Male participants
|
PRIMARY outcome
Timeframe: 3 web-based surveys over an average of 6-12 weeksPopulation: Numbers analyzed for each scale may differ from overall sample size as a function of sex (and hence opportunity to evaluate) or a non-evaluable scale for a given participant.
USPE Sum of averaged item means/# items (min:max 1:5); 1=Do not agree at all;2=Agree a little;3=Agree somewhat;4=Agree a lot;5=Agree completely. Products:Gel/Orange, Cream/Green, Liquid/Yellow. Initial Penetration:Smoothness/lubricity; Initial Lubrication:Coating/lubricating; Spreading Behavior:Ease of stroke, product spread; Product Awareness:Feel during sex (movement, felt betw rectal wall-penis); Perceived Wetness:Covering entire rectum, as after orgasm; Stimulating: enhanced pleasure; Messiness:Perceptions of messiness; Leakage:Sensations of leaking during/after sex, in pubic hair, cleanliness; Pre-coital Leakage:Product felt/leakage on body/clothes before sex; Naturalness:Sensation of naturalness, leakage looked like cum; Lubricity:Wetness before sex; slipperiness/lubricity during sex; Effortful:Effort needed at penetration; effort difficulty/dryness; Pleasure: Partner's stimulation; Noticeable: messiness, thickness Higher scores=greater agreement re:product characteristics
Outcome measures
| Measure |
Females
n=7 Participants
Female participants that reported user sensory perception experiences for 3 formulations.
|
Males
n=8 Participants
Male participants that reported user sensory perception experiences for 3 formulations.
|
|---|---|---|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Initial Penetration (Green)
|
3.67 units on a scale
Standard Deviation 1.11
|
3.29 units on a scale
Standard Deviation 1.71
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Initial Penetration (Orange)
|
3.86 units on a scale
Standard Deviation 1.35
|
3.42 units on a scale
Standard Deviation 1.32
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Initial Penetration (Yellow)
|
3.86 units on a scale
Standard Deviation 0.90
|
3.50 units on a scale
Standard Deviation 1.05
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Initial Lubrication (Green)
|
4.03 units on a scale
Standard Deviation 0.78
|
3.15 units on a scale
Standard Deviation 1.81
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Initial Lubrication (Orange)
|
3.74 units on a scale
Standard Deviation 0.96
|
3.78 units on a scale
Standard Deviation 1.06
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Initial Lubrication (Yellow)
|
4.17 units on a scale
Standard Deviation 0.55
|
3.23 units on a scale
Standard Deviation 1.44
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Spreading Behavior (Green)
|
3.62 units on a scale
Standard Deviation 1.22
|
3.25 units on a scale
Standard Deviation 1.19
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Spreading Behavior (Orange)
|
3.48 units on a scale
Standard Deviation 1.00
|
3.50 units on a scale
Standard Deviation 1.11
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Spreading Behavior (Yellow)
|
3.62 units on a scale
Standard Deviation 0.93
|
3.17 units on a scale
Standard Deviation 1.30
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Messiness (Green)
|
2.71 units on a scale
Standard Deviation 0.76
|
1.96 units on a scale
Standard Deviation 0.81
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Messiness (Orange)
|
2.19 units on a scale
Standard Deviation 0.72
|
1.79 units on a scale
Standard Deviation 0.86
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Messiness (Yellow)
|
2.40 units on a scale
Standard Deviation 1.04
|
2.74 units on a scale
Standard Deviation 1.38
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Perceived Wetness (Green)
|
3.68 units on a scale
Standard Deviation 1.12
|
2.82 units on a scale
Standard Deviation 1.40
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Perceived Wetness (Orange)
|
3.36 units on a scale
Standard Deviation 1.06
|
3.44 units on a scale
Standard Deviation 1.18
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Perceived Wetness (Yellow)
|
3.43 units on a scale
Standard Deviation 0.59
|
2.43 units on a scale
Standard Deviation 0.64
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Product Awareness (Green)
|
3.74 units on a scale
Standard Deviation 0.97
|
3.20 units on a scale
Standard Deviation 1.14
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Product Awareness (Orange)
|
3.84 units on a scale
Standard Deviation 0.91
|
2.89 units on a scale
Standard Deviation 0.99
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Product Awareness (Yellow)
|
3.73 units on a scale
Standard Deviation 0.61
|
3.38 units on a scale
Standard Deviation 1.23
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Leakage (Green)
|
2.86 units on a scale
Standard Deviation 1.53
|
2.56 units on a scale
Standard Deviation 1.15
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Leakage (Orange)
|
2.54 units on a scale
Standard Deviation 0.64
|
2.34 units on a scale
Standard Deviation 0.84
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Leakage (Yellow)
|
3.11 units on a scale
Standard Deviation 0.97
|
3.00 units on a scale
Standard Deviation 1.30
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Stimulating (Green)
|
2.86 units on a scale
Standard Deviation 1.32
|
2.24 units on a scale
Standard Deviation 0.93
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Stimulating (Orange)
|
2.83 units on a scale
Standard Deviation 0.63
|
2.71 units on a scale
Standard Deviation 1.24
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Stimulating (Yellow)
|
3.00 units on a scale
Standard Deviation 0.57
|
2.52 units on a scale
Standard Deviation 1.36
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Naturalness (Green)
|
2.43 units on a scale
Standard Deviation 0.51
|
2.18 units on a scale
Standard Deviation 0.76
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Naturalness (Orange)
|
2.36 units on a scale
Standard Deviation 0.73
|
2.75 units on a scale
Standard Deviation 1.21
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Naturalness (Yellow)
|
2.64 units on a scale
Standard Deviation 0.43
|
2.34 units on a scale
Standard Deviation 1.00
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Lubricity (Green)
|
3.52 units on a scale
Standard Deviation 1.23
|
2.50 units on a scale
Standard Deviation 0.91
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Lubricity (Orange)
|
3.95 units on a scale
Standard Deviation 0.56
|
3.13 units on a scale
Standard Deviation 0.94
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Lubricity (Yellow)
|
3.48 units on a scale
Standard Deviation 0.86
|
3.19 units on a scale
Standard Deviation 1.30
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Effortful (Green)
|
1.50 units on a scale
Standard Deviation 0.58
|
1.69 units on a scale
Standard Deviation 1.17
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Effortful (Orange)
|
1.43 units on a scale
Standard Deviation 1.13
|
1.97 units on a scale
Standard Deviation 1.28
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Effortful (Yellow)
|
1.36 units on a scale
Standard Deviation 0.48
|
1.59 units on a scale
Standard Deviation 0.67
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Pleasure (Green)
|
3.24 units on a scale
Standard Deviation 1.58
|
2.96 units on a scale
Standard Deviation 1.79
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Pleasure (Orange)
|
3.62 units on a scale
Standard Deviation 1.03
|
2.83 units on a scale
Standard Deviation 1.23
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Pleasure (Yellow)
|
3.52 units on a scale
Standard Deviation 0.96
|
2.33 units on a scale
Standard Deviation 0.98
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Pre-Coital Leakage (Green)
|
1.67 units on a scale
Standard Deviation 0.61
|
1.33 units on a scale
Standard Deviation 0.67
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Pre-Coital Leakage (Orange)
|
1.75 units on a scale
Standard Deviation 1.10
|
1.33 units on a scale
Standard Deviation 0.67
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Pre-Coital Leakage (Yellow)
|
2.00 units on a scale
|
1.87 units on a scale
Standard Deviation 1.26
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Noticeable (Green)
|
3.10 units on a scale
Standard Deviation 1.30
|
2.79 units on a scale
Standard Deviation 1.15
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Noticeable (Orange)
|
2.85 units on a scale
Standard Deviation 1.00
|
2.63 units on a scale
Standard Deviation 1.05
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Noticeable (Yellow)
|
2.90 units on a scale
Standard Deviation 0.74
|
2.25 units on a scale
Standard Deviation 0.89
|
Adverse Events
Females
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Males
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Females
n=7 participants at risk
Female participants evaluating three formulations: Gel/Orange; Cream/Green; Liquid/Yellow
|
Males
n=8 participants at risk
Male participants evaluating three formulations: Gel/Orange; Cream/Green; Liquid/Yellow
|
|---|---|---|
|
Gastrointestinal disorders
Anorectal pain (Green)
|
14.3%
1/7 • Number of events 1 • 6-12 weeks
Adverse events are combined across arms (Gel/Orange, Cream/Green, Liquid/Yellow) and separated by sex only, since only 1 adverse event with the Cream/Green product was reported overall (female, Cream/Green).
|
0.00%
0/8 • 6-12 weeks
Adverse events are combined across arms (Gel/Orange, Cream/Green, Liquid/Yellow) and separated by sex only, since only 1 adverse event with the Cream/Green product was reported overall (female, Cream/Green).
|
Additional Information
Dr Kate Guthrie, Co-Investigator, Project DRUM Lead Investigator
The Miriam Hospital
Phone: (401) 793-8180
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place