Trial Outcomes & Findings for A Formative Study to Explore the Sensory Perceptions of Vaginal Product Users (NCT NCT01334827)
NCT ID: NCT01334827
Last Updated: 2025-10-15
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:Low volume gel, high volume gel, film.Initial Penetration:Smoothness/lubricity; Initial Lubrication:Coating/lubricating; Spreading Behavior:Ease of stroke, product spread; Product Awareness:Feel intravaginally during sex (movement, felt betw vaginal wall-penis); Perceived Wetness:Covering entire vagina; as after orgasm; Stimulating: enhanced pleasure; Messiness:Perceptions of watery/messiness; Leakage:Sensations of leaking during/after sex; in pubic hair; need to clean; Pre-coital Leakage:Product felt/leakage noticed on panty liner before sex; Naturalness:Sensation of naturalness; leakage looked like vaginal fluid; Lubricity:Wetness before sex; slipperiness/lubricity during sex; Effortful:Effort needed at penetration; effort difficulty/dryness; Pleasure:Partner's stimulation; Noticeable:Male sensation during sex, messiness, thickness
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
4-5 visits over an average of 8-12 weeks
Results posted on
2025-10-15
Participant Flow
Recruited (RI, MA USA) via call-lists, flyers, ads, internet/social media, clinics, CBOs, word-of-mouth.
Participant milestones
| Measure |
Female and Male Members of Monogamous Couples
Heterosexual mutually monogamous couples in good general health evaluate 3 topical vaginal formulations (all placebo)
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
COMPLETED
|
48
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only females assessed
Baseline characteristics by cohort
| Measure |
Female Member of Couple Enrolled
n=24 Participants
Heterosexual mutually monogamous couples in good general health evaluate 3 topical vaginal formulations (all placebo)
|
Male Member of Couple Enrolled
n=24 Participants
Heterosexual mutually monogamous couples in good general health evaluate 3 topical vaginal formulations (all placebo)
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-29
|
12 Participants
n=24 Participants
|
12 Participants
n=24 Participants
|
24 Participants
n=48 Participants
|
|
Age, Customized
30+
|
12 Participants
n=24 Participants
|
12 Participants
n=24 Participants
|
24 Participants
n=48 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
24 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
24 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
5 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=24 Participants
|
22 Participants
n=24 Participants
|
43 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=24 Participants
|
4 Participants
n=24 Participants
|
7 Participants
n=48 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=24 Participants
|
17 Participants
n=24 Participants
|
32 Participants
n=48 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=24 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=48 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=24 Participants
|
24 Participants
n=24 Participants
|
48 Participants
n=48 Participants
|
|
Current Contraceptive Use
Hormonal Contraceptive
|
17 Participants
n=24 Participants • Only females assessed
|
—
|
17 Participants
n=24 Participants • Only females assessed
|
|
Current Contraceptive Use
Non-Hormonal Contraceptive
|
7 Participants
n=24 Participants • Only females assessed
|
—
|
7 Participants
n=24 Participants • Only females assessed
|
|
History of STD diagnosis
|
4 Participants
n=24 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=48 Participants
|
|
Yearly Income
Less than $15,000 annually
|
12 Participants
n=24 Participants
|
6 Participants
n=24 Participants
|
18 Participants
n=48 Participants
|
|
Yearly Income
$15,000-$36,000 annually
|
7 Participants
n=24 Participants
|
10 Participants
n=24 Participants
|
17 Participants
n=48 Participants
|
|
Yearly Income
More than $36,000 annually
|
5 Participants
n=24 Participants
|
8 Participants
n=24 Participants
|
13 Participants
n=48 Participants
|
|
Vaginal Deliveries
|
9 Participants
n=24 Participants • Only females assessed
|
—
|
9 Participants
n=24 Participants • Only females assessed
|
PRIMARY outcome
Timeframe: 4-5 visits over an average of 8-12 weeksPopulation: Perceived Pre-Sex Leakage not applicable for Male members of enrolled couples
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:Low volume gel, high volume gel, film.Initial Penetration:Smoothness/lubricity; Initial Lubrication:Coating/lubricating; Spreading Behavior:Ease of stroke, product spread; Product Awareness:Feel intravaginally during sex (movement, felt betw vaginal wall-penis); Perceived Wetness:Covering entire vagina; as after orgasm; Stimulating: enhanced pleasure; Messiness:Perceptions of watery/messiness; Leakage:Sensations of leaking during/after sex; in pubic hair; need to clean; Pre-coital Leakage:Product felt/leakage noticed on panty liner before sex; Naturalness:Sensation of naturalness; leakage looked like vaginal fluid; Lubricity:Wetness before sex; slipperiness/lubricity during sex; Effortful:Effort needed at penetration; effort difficulty/dryness; Pleasure:Partner's stimulation; Noticeable:Male sensation during sex, messiness, thickness
Outcome measures
| Measure |
Female Members
n=24 Participants
Heterosexual mutually monogamous couples in good general health evaluate 3 topical vaginal formulations (all placebo)
|
Male Members
n=24 Participants
Heterosexual mutually monogamous couples in good general health evaluate 3 topical vaginal formulations (all placebo)
|
|---|---|---|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Initial Penetration [Low Volume Gel]
|
3.64 units on a scale
Standard Deviation 1.20
|
3.86 units on a scale
Standard Deviation 0.75
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Initial Penetration [High Volume Gel]
|
4.35 units on a scale
Standard Deviation 0.76
|
3.83 units on a scale
Standard Deviation 0.74
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Initial Penetration [Film]
|
1.74 units on a scale
Standard Deviation 1.16
|
2.06 units on a scale
Standard Deviation 1.03
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Initial Lubrication [Low Volume Gel]
|
3.54 units on a scale
Standard Deviation 1.22
|
3.58 units on a scale
Standard Deviation 0.72
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Initial Lubrication [High Volume Gel]
|
3.89 units on a scale
Standard Deviation 1.02
|
3.78 units on a scale
Standard Deviation 0.77
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Initial Lubrication [Film]
|
2.55 units on a scale
Standard Deviation 1.27
|
2.60 units on a scale
Standard Deviation 1.04
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Product Awareness [Low Volume Gel]
|
2.55 units on a scale
Standard Deviation 0.94
|
2.72 units on a scale
Standard Deviation 0.95
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Product Awareness [High Volume Gel]
|
2.89 units on a scale
Standard Deviation 1.10
|
3.10 units on a scale
Standard Deviation 1.16
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Product Awareness [Film]
|
1.73 units on a scale
Standard Deviation 0.68
|
2.04 units on a scale
Standard Deviation 0.88
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Perceived Wetness [Low Volume Gel]
|
2.88 units on a scale
Standard Deviation 1.33
|
3.00 units on a scale
Standard Deviation 0.91
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Perceived Wetness [High Volume Gel]
|
3.43 units on a scale
Standard Deviation 0.95
|
3.38 units on a scale
Standard Deviation 1.04
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Perceived Wetness [Film]
|
1.74 units on a scale
Standard Deviation 0.85
|
1.94 units on a scale
Standard Deviation 0.86
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Stimulating [Low Volume Gel]
|
2.35 units on a scale
Standard Deviation 1.05
|
2.58 units on a scale
Standard Deviation 1.04
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Stimulating [High Volume Gel]
|
2.72 units on a scale
Standard Deviation 0.85
|
2.66 units on a scale
Standard Deviation 0.98
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Stimulating [Film]
|
1.36 units on a scale
Standard Deviation 0.73
|
1.99 units on a scale
Standard Deviation 0.92
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Messiness [Low Volume Gel]
|
1.65 units on a scale
Standard Deviation 0.69
|
1.84 units on a scale
Standard Deviation 0.70
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Messiness [High Volume Gel]
|
2.11 units on a scale
Standard Deviation 0.81
|
2.18 units on a scale
Standard Deviation 0.80
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Messiness [Film]
|
1.39 units on a scale
Standard Deviation 0.49
|
1.32 units on a scale
Standard Deviation 0.33
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Perceived Leakage [Low Volume Gel]
|
2.05 units on a scale
Standard Deviation 0.89
|
1.73 units on a scale
Standard Deviation 0.57
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Perceived Leakage [High Volume Gel]
|
2.44 units on a scale
Standard Deviation 0.95
|
2.10 units on a scale
Standard Deviation 0.77
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Perceived Leakage [Film]
|
1.48 units on a scale
Standard Deviation 0.62
|
1.38 units on a scale
Standard Deviation 0.45
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Perceived Naturalness [Low Volume Gel]
|
3.38 units on a scale
Standard Deviation 0.81
|
3.17 units on a scale
Standard Deviation 0.95
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Perceived Naturalness [High Volume Gel]
|
3.44 units on a scale
Standard Deviation 0.93
|
3.17 units on a scale
Standard Deviation 0.97
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Perceived Naturalness [Film]
|
2.40 units on a scale
Standard Deviation 1.23
|
2.60 units on a scale
Standard Deviation 1.42
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Perceived Lubricity [Low Volume Gel]
|
3.10 units on a scale
Standard Deviation 1.20
|
3.15 units on a scale
Standard Deviation 1.10
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Perceived Lubricity [High Volume Gel]
|
3.50 units on a scale
Standard Deviation 1.08
|
3.42 units on a scale
Standard Deviation 1.05
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Perceived Lubricity [Film]
|
1.38 units on a scale
Standard Deviation 0.63
|
1.63 units on a scale
Standard Deviation 0.80
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Effortful [Low Volume Gel]
|
1.41 units on a scale
Standard Deviation 0.59
|
1.53 units on a scale
Standard Deviation 0.76
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Effortful [High Volume Gel]
|
1.17 units on a scale
Standard Deviation 0.46
|
1.19 units on a scale
Standard Deviation 0.47
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Effortful [Film]
|
3.08 units on a scale
Standard Deviation 1.53
|
2.81 units on a scale
Standard Deviation 1.26
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Pleasure [Low Volume Gel]
|
2.35 units on a scale
Standard Deviation 0.97
|
2.88 units on a scale
Standard Deviation 0.82
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Pleasure [High Volume Gel]
|
2.93 units on a scale
Standard Deviation 1.04
|
2.92 units on a scale
Standard Deviation 1.00
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Pleasure [Film]
|
1.43 units on a scale
Standard Deviation 0.87
|
2.08 units on a scale
Standard Deviation 0.90
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Perceived Pre-Sex Leakage [Low Volume Gel]
|
2.08 units on a scale
Standard Deviation 1.34
|
—
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Perceived Pre-Sex Leakage [High Volume Gel]
|
2.89 units on a scale
Standard Deviation 1.49
|
—
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Perceived Pre-Sex Leakage [Film]
|
1.25 units on a scale
Standard Deviation 0.72
|
—
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Noticeable [Low Volume Gel]
|
2.14 units on a scale
Standard Deviation 1.00
|
2.54 units on a scale
Standard Deviation 1.01
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Noticeable [High Volume Gel]
|
2.65 units on a scale
Standard Deviation 1.29
|
2.89 units on a scale
Standard Deviation 1.07
|
|
User Sensory Perception & Experience (USPE; Perceptibility) Scale Item Means
SEX: Noticeable [Film]
|
1.75 units on a scale
Standard Deviation 1.19
|
1.78 units on a scale
Standard Deviation 0.78
|
Adverse Events
Females
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Males
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Females
n=24 participants at risk
Female member of couple enrolled
|
Males
n=24 participants at risk
Male member of couple enrolled
|
|---|---|---|
|
Reproductive system and breast disorders
Vaginal Dryness
|
20.8%
5/24 • Number of events 5 • On average, 12 to 16 weeks
|
0.00%
0/24 • On average, 12 to 16 weeks
|
|
Reproductive system and breast disorders
Pain (vaginal introitus; penis)
|
4.2%
1/24 • Number of events 1 • On average, 12 to 16 weeks
|
4.2%
1/24 • Number of events 1 • On average, 12 to 16 weeks
|
Additional Information
Dr Kate Guthrie, Co-Investigator, Project MIST 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