Trial Outcomes & Findings for Developing Rectal USPE Measures for Suppositories (Project DRUM-S) (NCT NCT02744261)
NCT ID: NCT02744261
Last Updated: 2026-02-10
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, Suppository 1/Green, Suppository 2/Yellow. Initial Penetration:Smoothness/lubricity; Initial Lubrication:Coating/lubricating; Spreading Behavior:Ease of stroke, product spread; Product Awareness:Feel during sex (movement, felt betw vaginal/rectal wall-penis); Perceived Wetness:Covering entire vagina/rectum; Stimulating:enhanced pleasure; Messiness:Perceptions of messiness; Leakage:Sensations of leaking during/after sex; Pre-coital Leakage:Product felt/leakage on body or clothes before sex; Naturalness:Sensation of naturalness; leakage looked like vag fluid/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
32 participants
Primary outcome timeframe
Web-based survey (same survey; 3 times; one for each formulation) over an average of 6-12 weeks
Results posted on
2026-02-10
Participant Flow
Recruited (RI, MA USA) via call-lists, flyers, ads, internet/social media, clinics, CBOs, word-of-mouth.
One female participant was withdrawn prior to use of any study products. She was not able to follow study guidelines and did not use her first study product within the allotted time (I.e., did not use any of the three products).
Participant milestones
| Measure |
Females
Female participants that reported user sensory perception experiences for 3 formulations (Orange/Gel, Green/Suppository 1, and Yellow/Suppository 2) during Receptive Anal Intercourse (RAI), and 2 formulations (Green/Suppository 1 and Yellow/Suppository 2) during Receptive Vaginal Intercourse (RVI).
|
Males
Male participants that reported user sensory perception experiences for 3 formulations (Orange/Gel, Green/Suppository 1, and Yellow/Suppository 2) during Receptive Anal Intercourse (RAI).
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
15
|
|
Overall Study
Orange/Gel use
|
16
|
13
|
|
Overall Study
Green/Suppository 1 use
|
15
|
15
|
|
Overall Study
Yellow/Suppository 2 use
|
16
|
15
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Females
Female participants that reported user sensory perception experiences for 3 formulations (Orange/Gel, Green/Suppository 1, and Yellow/Suppository 2) during Receptive Anal Intercourse (RAI), and 2 formulations (Green/Suppository 1 and Yellow/Suppository 2) during Receptive Vaginal Intercourse (RVI).
|
Males
Male participants that reported user sensory perception experiences for 3 formulations (Orange/Gel, Green/Suppository 1, and Yellow/Suppository 2) during Receptive Anal Intercourse (RAI).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Vaginal deliveries does not apply to Male participants
Baseline characteristics by cohort
| Measure |
Females
n=16 Participants
Female participants that reported user sensory perception experiences for 3 formulations (Gel, Suppository 1, and Suppository 2) during Receptive Anal Intercourse (RAI), and 2 formulations (Suppository 1 and Suppository 2) during Receptive Vaginal Intercourse (RVI).
|
Males
n=15 Participants
Male participants that reported user sensory perception experiences for 3 formulations (Gel, Suppository 1, and Suppository 2) during Receptive Anal Intercourse (RAI).
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
0 Participants
n=16 Participants
|
15 Participants
n=15 Participants
|
15 Participants
n=31 Participants
|
|
Age, Customized
18-29 years
|
11 Participants
n=16 Participants
|
4 Participants
n=15 Participants
|
15 Participants
n=31 Participants
|
|
Age, Customized
30+ years
|
5 Participants
n=16 Participants
|
11 Participants
n=15 Participants
|
16 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
16 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=16 Participants
|
10 Participants
n=15 Participants
|
20 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=16 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
1 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
More Than One Race (Black/African American, White and American Indian/Alaska Native)
|
1 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
More Than One Race (White and American Indian/Alaska Native)
|
0 Participants
n=16 Participants
|
3 Participants
n=15 Participants
|
3 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other Race (Not specified)
|
0 Participants
n=16 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Refused
|
3 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
3 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latinx
|
4 Participants
n=16 Participants
|
2 Participants
n=15 Participants
|
6 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=16 Participants
|
15 participants
n=15 Participants
|
31 participants
n=31 Participants
|
|
Yearly Income
Less than $15,000
|
6 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
6 Participants
n=31 Participants
|
|
Yearly Income
$15,000 - $36,000
|
9 Participants
n=16 Participants
|
3 Participants
n=15 Participants
|
12 Participants
n=31 Participants
|
|
Yearly Income
More than $36,000
|
1 Participants
n=16 Participants
|
11 Participants
n=15 Participants
|
12 Participants
n=31 Participants
|
|
Yearly Income
Refused to Answer
|
0 Participants
n=16 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=31 Participants
|
|
History of STD Diagnosis
|
4 Participants
n=16 Participants
|
4 Participants
n=15 Participants
|
8 Participants
n=31 Participants
|
|
Vaginal Deliveries
|
4 Participants
n=16 Participants • Vaginal deliveries does not apply to Male participants
|
—
|
4 Participants
n=16 Participants • Vaginal deliveries does not apply to Male participants
|
PRIMARY outcome
Timeframe: Web-based survey (same survey; 3 times; one for each formulation) 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, Suppository 1/Green, Suppository 2/Yellow. Initial Penetration:Smoothness/lubricity; Initial Lubrication:Coating/lubricating; Spreading Behavior:Ease of stroke, product spread; Product Awareness:Feel during sex (movement, felt betw vaginal/rectal wall-penis); Perceived Wetness:Covering entire vagina/rectum; Stimulating:enhanced pleasure; Messiness:Perceptions of messiness; Leakage:Sensations of leaking during/after sex; Pre-coital Leakage:Product felt/leakage on body or clothes before sex; Naturalness:Sensation of naturalness; leakage looked like vag fluid/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=16 Participants
Female participants that reported user sensory perception experiences for 3 formulations (Gel, Suppository 1, and Suppository 2) during Receptive Anal Intercourse (RAI), and 2 formulations (Suppository 1 and Suppository 2) during Receptive Vaginal Intercourse (RVI).
|
Males
n=15 Participants
Male participants that reported user sensory perception experiences for 3 formulations (Gel, Suppository 1, and Suppository 2) during Receptive Anal Intercourse (RAI).
|
|---|---|---|
|
User Perception Scale Scores
SEX: Naturalness - RVI (Green)
|
1.88 units on a scale
Standard Deviation 1.04
|
—
|
|
User Perception Scale Scores
SEX: Lubricity - RVI (Yellow)
|
3.38 units on a scale
Standard Deviation 1.02
|
—
|
|
User Perception Scale Scores
SEX: Lubricity - RVI (Green)
|
1.91 units on a scale
Standard Deviation 1.01
|
—
|
|
User Perception Scale Scores
SEX: Effortful - RVI (Yellow)
|
1.23 units on a scale
Standard Deviation 0.36
|
—
|
|
User Perception Scale Scores
SEX: Pleasure - RVI (Yellow)
|
2.55 units on a scale
Standard Deviation 1.14
|
—
|
|
User Perception Scale Scores
SEX: Pleasure - RVI (Green)
|
1.43 units on a scale
Standard Deviation 0.77
|
—
|
|
User Perception Scale Scores
SEX: Lubricity - RAI (Green)
|
2.20 units on a scale
Standard Deviation 1.37
|
2.31 units on a scale
Standard Deviation 0.91
|
|
User Perception Scale Scores
SEX: Lubricity - RAI (Orange)
|
2.54 units on a scale
Standard Deviation 1.10
|
2.61 units on a scale
Standard Deviation 1.16
|
|
User Perception Scale Scores
SEX: Effortful - RAI (Yellow)
|
1.75 units on a scale
Standard Deviation 0.84
|
1.68 units on a scale
Standard Deviation 0.66
|
|
User Perception Scale Scores
SEX: Effortful - RAI (Green)
|
2.67 units on a scale
Standard Deviation 1.37
|
2.12 units on a scale
Standard Deviation 1.12
|
|
User Perception Scale Scores
SEX: Effortful - RAI (Orange)
|
1.80 units on a scale
Standard Deviation 0.87
|
1.46 units on a scale
Standard Deviation 0.37
|
|
User Perception Scale Scores
SEX: Pleasure - RAI (Yellow)
|
2.78 units on a scale
Standard Deviation 1.22
|
3.12 units on a scale
Standard Deviation 1.32
|
|
User Perception Scale Scores
SEX: Pleasure - RAI (Green)
|
2.04 units on a scale
Standard Deviation 1.45
|
2.40 units on a scale
Standard Deviation 1.16
|
|
User Perception Scale Scores
SEX: Pleasure - RAI (Orange)
|
2.42 units on a scale
Standard Deviation 1.45
|
3.06 units on a scale
Standard Deviation 1.09
|
|
User Perception Scale Scores
SEX: PreCoital Leakage - RAI (Yellow)
|
1.35 units on a scale
Standard Deviation 0.58
|
1.24 units on a scale
Standard Deviation 0.46
|
|
User Perception Scale Scores
SEX: PreCoital Leakage - RAI (Green)
|
1.18 units on a scale
Standard Deviation 0.33
|
1.51 units on a scale
Standard Deviation 0.99
|
|
User Perception Scale Scores
SEX: PreCoital Leakage - RVI (Yellow)
|
1.69 units on a scale
Standard Deviation 0.81
|
—
|
|
User Perception Scale Scores
SEX: PreCoital Leakage - RVI (Green)
|
1.44 units on a scale
Standard Deviation 0.99
|
—
|
|
User Perception Scale Scores
SEX: Noticeable - RVI (Yellow)
|
2.05 units on a scale
Standard Deviation 1.05
|
—
|
|
User Perception Scale Scores
SEX: Noticeable - RVI (Green)
|
3.40 units on a scale
Standard Deviation 0.89
|
—
|
|
User Perception Scale Scores
SEX: Initial Penetration - RAI (Yellow)
|
3.31 units on a scale
Standard Deviation 1.14
|
3.36 units on a scale
Standard Deviation 1.29
|
|
User Perception Scale Scores
SEX: Initial Penetration - RAI (Green)
|
2.12 units on a scale
Standard Deviation 1.45
|
2.62 units on a scale
Standard Deviation 1.25
|
|
User Perception Scale Scores
SEX: Initial Penetration - RAI (Orange)
|
3.06 units on a scale
Standard Deviation 1.42
|
3.08 units on a scale
Standard Deviation 1.30
|
|
User Perception Scale Scores
SEX: Initial Lubrication - RAI (Yellow)
|
3.63 units on a scale
Standard Deviation 1.02
|
3.32 units on a scale
Standard Deviation 1.15
|
|
User Perception Scale Scores
SEX: Initial Lubrication - RAI (Green)
|
2.61 units on a scale
Standard Deviation 1.42
|
2.85 units on a scale
Standard Deviation 1.17
|
|
User Perception Scale Scores
SEX: Initial Lubrication - RAI (Orange)
|
2.84 units on a scale
Standard Deviation 1.20
|
3.42 units on a scale
Standard Deviation 1.42
|
|
User Perception Scale Scores
SEX: Spreading Behavior - RAI (Yellow)
|
3.44 units on a scale
Standard Deviation 1.08
|
3.22 units on a scale
Standard Deviation 1.36
|
|
User Perception Scale Scores
SEX: Spreading Behavior - RAI (Green)
|
2.98 units on a scale
Standard Deviation 1.01
|
3.18 units on a scale
Standard Deviation 0.88
|
|
User Perception Scale Scores
SEX: Spreading Behavior - RAI (Orange)
|
2.98 units on a scale
Standard Deviation 1.16
|
3.28 units on a scale
Standard Deviation 0.86
|
|
User Perception Scale Scores
SEX: Messiness - RAI (Yellow)
|
1.98 units on a scale
Standard Deviation 0.75
|
1.78 units on a scale
Standard Deviation 0.75
|
|
User Perception Scale Scores
SEX: Messiness - RAI (Green)
|
1.79 units on a scale
Standard Deviation 0.67
|
1.82 units on a scale
Standard Deviation 0.86
|
|
User Perception Scale Scores
SEX: Messiness - RAI (Orange)
|
1.77 units on a scale
Standard Deviation 0.66
|
1.78 units on a scale
Standard Deviation 0.90
|
|
User Perception Scale Scores
SEX: Perceived Wetness - RAI (Yellow)
|
2.77 units on a scale
Standard Deviation 0.97
|
2.77 units on a scale
Standard Deviation 1.05
|
|
User Perception Scale Scores
SEX: Perceived Wetness - RAI (Green)
|
2.30 units on a scale
Standard Deviation 1.15
|
2.20 units on a scale
Standard Deviation 0.67
|
|
User Perception Scale Scores
SEX: Perceived Wetness - RAI (Orange)
|
2.43 units on a scale
Standard Deviation 1.11
|
2.60 units on a scale
Standard Deviation 0.94
|
|
User Perception Scale Scores
SEX: Product Awareness - RAI (Yellow)
|
2.29 units on a scale
Standard Deviation 0.75
|
2.85 units on a scale
Standard Deviation 1.11
|
|
User Perception Scale Scores
SEX: Product Awareness - RAI (Green)
|
2.76 units on a scale
Standard Deviation 1.10
|
2.63 units on a scale
Standard Deviation 0.91
|
|
User Perception Scale Scores
SEX: Product Awareness - RAI (Orange)
|
2.38 units on a scale
Standard Deviation 0.82
|
3.32 units on a scale
Standard Deviation 0.97
|
|
User Perception Scale Scores
SEX: Leakage - RAI (Yellow)
|
2.31 units on a scale
Standard Deviation 1.01
|
2.17 units on a scale
Standard Deviation 0.98
|
|
User Perception Scale Scores
SEX: Leakage - RAI (Green)
|
1.85 units on a scale
Standard Deviation 0.85
|
2.12 units on a scale
Standard Deviation 0.87
|
|
User Perception Scale Scores
SEX: Leakage - RAI (Orange)
|
2.14 units on a scale
Standard Deviation 0.93
|
2.29 units on a scale
Standard Deviation 0.92
|
|
User Perception Scale Scores
SEX: Stimulating - RAI (Yellow)
|
2.50 units on a scale
Standard Deviation 0.95
|
2.93 units on a scale
Standard Deviation 1.35
|
|
User Perception Scale Scores
SEX: Stimulating - RAI (Green)
|
1.68 units on a scale
Standard Deviation 1.09
|
2.43 units on a scale
Standard Deviation 1.13
|
|
User Perception Scale Scores
SEX: Stimulating - RAI (Orange)
|
2.16 units on a scale
Standard Deviation 1.00
|
2.49 units on a scale
Standard Deviation 0.94
|
|
User Perception Scale Scores
SEX: Naturalness - RAI (Yellow)
|
2.86 units on a scale
Standard Deviation 0.72
|
2.44 units on a scale
Standard Deviation 0.59
|
|
User Perception Scale Scores
SEX: Naturalness - RAI (Green)
|
1.68 units on a scale
Standard Deviation 0.82
|
2.10 units on a scale
Standard Deviation 0.67
|
|
User Perception Scale Scores
SEX: Naturalness - RAI (Orange)
|
2.31 units on a scale
Standard Deviation 0.93
|
2.02 units on a scale
Standard Deviation 0.66
|
|
User Perception Scale Scores
SEX: Lubricity - RAI (Yellow)
|
3.25 units on a scale
Standard Deviation 1.22
|
2.48 units on a scale
Standard Deviation 0.85
|
|
User Perception Scale Scores
SEX: PreCoital Leakage - RAI (Orange)
|
1.21 units on a scale
Standard Deviation 0.38
|
1.74 units on a scale
Standard Deviation 1.13
|
|
User Perception Scale Scores
SEX: Noticeable - RAI (Yellow)
|
2.27 units on a scale
Standard Deviation 1.08
|
2.33 units on a scale
Standard Deviation 0.76
|
|
User Perception Scale Scores
SEX: Noticeable - RAI (Green)
|
2.89 units on a scale
Standard Deviation 1.23
|
2.02 units on a scale
Standard Deviation 0.70
|
|
User Perception Scale Scores
SEX: Noticeable - RAI (Orange)
|
1.96 units on a scale
Standard Deviation 0.85
|
2.23 units on a scale
Standard Deviation 0.80
|
|
User Perception Scale Scores
SEX: Initial Penetration - RVI (Yellow)
|
3.73 units on a scale
Standard Deviation 0.85
|
—
|
|
User Perception Scale Scores
SEX Initial Penetration - RVI (Green)
|
2.44 units on a scale
Standard Deviation 1.37
|
—
|
|
User Perception Scale Scores
SEX: Initial Lubrication - RVI (Yellow)
|
3.80 units on a scale
Standard Deviation 0.97
|
—
|
|
User Perception Scale Scores
SEX: Initial Lubrication - RVI (Green)
|
2.89 units on a scale
Standard Deviation 1.27
|
—
|
|
User Perception Scale Scores
SEX: Spreading Behavior - RVI (Yellow)
|
3.67 units on a scale
Standard Deviation 0.86
|
—
|
|
User Perception Scale Scores
SEX: Spreading Behavior - RVI (Orange)
|
3.17 units on a scale
Standard Deviation 1.13
|
—
|
|
User Perception Scale Scores
SEX: Messiness - RVI (Yellow)
|
2.34 units on a scale
Standard Deviation 0.79
|
—
|
|
User Perception Scale Scores
SEX: Messiness - RVI (Green)
|
2.33 units on a scale
Standard Deviation 0.86
|
—
|
|
User Perception Scale Scores
SEX: Perceived Wetness - RVI (Yellow)
|
3.18 units on a scale
Standard Deviation 1.18
|
—
|
|
User Perception Scale Scores
SEX: Perceived Wetness - RVI (Green)
|
2.35 units on a scale
Standard Deviation 1.13
|
—
|
|
User Perception Scale Scores
SEX: Product Awareness - RVI (Yellow)
|
2.33 units on a scale
Standard Deviation 0.78
|
—
|
|
User Perception Scale Scores
SEX: Product Awareness - RVI (Green)
|
2.66 units on a scale
Standard Deviation 0.72
|
—
|
|
User Perception Scale Scores
SEX: Leakage - RVI (Yellow)
|
2.56 units on a scale
Standard Deviation 1.04
|
—
|
|
User Perception Scale Scores
SEX: Leakage - RVI (Green)
|
2.31 units on a scale
Standard Deviation 0.97
|
—
|
|
User Perception Scale Scores
SEX: Stimulating - RVI (Yellow)
|
2.31 units on a scale
Standard Deviation 1.13
|
—
|
|
User Perception Scale Scores
SEX: Stimulating - RVI (Green)
|
1.53 units on a scale
Standard Deviation 0.91
|
—
|
|
User Perception Scale Scores
SEX: Naturalness - RVI (Yellow)
|
2.82 units on a scale
Standard Deviation 0.94
|
—
|
|
User Perception Scale Scores
SEX: Effortful - RVI (Green)
|
2.75 units on a scale
Standard Deviation 1.60
|
—
|
Adverse Events
Females Gel/Orange
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Females Suppository 1/Green
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Females Suppository 2/Yellow
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Males Gel/Orange
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Males Suppository 1/Green
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Males Suppository 2/Yellow
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Females Gel/Orange
n=16 participants at risk
Female participants that reported user sensory perception experiences for Gel/Orange during Receptive Anal Intercourse (RAI).
|
Females Suppository 1/Green
n=15 participants at risk
Female participants that reported user sensory perception experiences for Suppository 1/Green during Receptive Anal Intercourse (RAI) and Receptive Vaginal Intercourse (RVI).
|
Females Suppository 2/Yellow
n=16 participants at risk
Female participants that reported user sensory perception experiences for Suppository 2/Yellow during Receptive Anal Intercourse (RAI) and Receptive Vaginal Intercourse (RVI).
|
Males Gel/Orange
n=13 participants at risk
Male participants that reported user sensory perception experiences for Gel/Orange during Receptive Anal Intercourse (RAI).
|
Males Suppository 1/Green
n=15 participants at risk
Male participants that reported user sensory perception experiences for Suppository 1/Green during Receptive Anal Intercourse (RAI).
|
Males Suppository 2/Yellow
n=15 participants at risk
Male participants that reported user sensory perception experiences for Suppository 2/Yellow during Receptive Anal Intercourse (RAI).
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Yeast Infection
|
0.00%
0/16 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
6.7%
1/15 • Number of events 1 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/16 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/13 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/15 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/15 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
|
Reproductive system and breast disorders
Vaginal Burning
|
0.00%
0/16 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
6.7%
1/15 • Number of events 1 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/16 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
—
0/0 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
—
0/0 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
—
0/0 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
|
Gastrointestinal disorders
Anorectal Burning
|
6.2%
1/16 • Number of events 1 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/15 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/16 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/13 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
6.7%
1/15 • Number of events 1 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/15 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
|
Gastrointestinal disorders
Pain with RAI Only
|
0.00%
0/16 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/15 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
6.2%
1/16 • Number of events 1 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/13 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/15 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/15 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
|
Reproductive system and breast disorders
Pain with RAI and RVI
|
0.00%
0/16 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/15 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
6.2%
1/16 • Number of events 1 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
—
0/0 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
—
0/0 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
—
0/0 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
|
Renal and urinary disorders
Burning While Urinating
|
0.00%
0/16 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/15 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/16 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
7.7%
1/13 • Number of events 1 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/15 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/15 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/15 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/16 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/13 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/15 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
6.7%
1/15 • Number of events 1 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
|
Gastrointestinal disorders
Intestinal Cramping/Gassiness
|
0.00%
0/16 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/15 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/16 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
7.7%
1/13 • Number of events 1 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
0.00%
0/15 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
6.7%
1/15 • Number of events 1 • 6-12 weeks
Adverse events are separated across arms (Females Gel/Orange, Females Suppository 1/Green, Females Suppository 2/Yellow, Males Gel/Orange, Males Suppository 1/Green, Males Suppository 2/Yellow). Some events are specific to Females and do not apply to Males (Vaginal burning and pain during RVI (receptive vaginal intercourse).
|
Additional Information
Dr Kate Guthrie, Co-Investigator, Project DRUM-S 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