Trial Outcomes & Findings for Randomized Cross-Over Study of Self-Insertion of Two Placebo Vaginal Film Formulations (NCT NCT04391036)
NCT ID: NCT04391036
Last Updated: 2022-02-22
Results Overview
Number of participants that successfully insert each vaginal film defined as the film location being completely inside the vagina upon visual assessment by a clinician
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Approximately 30 minutes
Results posted on
2022-02-22
Participant Flow
Participant milestones
| Measure |
High Eudragit® Film, Then Low Eudragit® Film
High (12.8%) Eudragit® content vaginal film, then low (6.4%) Eudragit® content vaginal film
High Eudragit® Content Vaginal Film: High (12.8%) Eudragit® Content Vaginal Film
Low Eudragit® Content Vaginal Film: Low (6.4%) Eudragit® Content Vaginal Film
|
Low Eudragit® Film, Then High Eudragit® Film
Low (6.4%) Eudragit® content vaginal film, then high (12.8%) Eudragit® content vaginal film
High Eudragit® Content Vaginal Film: High (12.8%) Eudragit® Content Vaginal Film
Low Eudragit® Content Vaginal Film: Low (6.4%) Eudragit® Content Vaginal Film
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Cross-Over Study of Self-Insertion of Two Placebo Vaginal Film Formulations
Baseline characteristics by cohort
| Measure |
High Eudragit® Film, Then Low Eudragit® Film
n=15 Participants
High (12.8%) Eudragit® content vaginal film, then low (6.4%) Eudragit® content vaginal film
High Eudragit® Content Vaginal Film: High (12.8%) Eudragit® Content Vaginal Film
Low Eudragit® Content Vaginal Film: Low (6.4%) Eudragit® Content Vaginal Film
|
Low Eudragit® Film, Then High Eudragit® Film
n=15 Participants
Low (6.4%) Eudragit® content vaginal film, then high (12.8%) Eudragit® content vaginal film
High Eudragit® Content Vaginal Film: High (12.8%) Eudragit® Content Vaginal Film
Low Eudragit® Content Vaginal Film: Low (6.4%) Eudragit® Content Vaginal Film
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.5 years
STANDARD_DEVIATION 8.6 • n=93 Participants
|
28.1 years
STANDARD_DEVIATION 5.3 • n=4 Participants
|
29.8 years
STANDARD_DEVIATION 7.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=93 Participants
|
15 participants
n=4 Participants
|
30 participants
n=27 Participants
|
|
Body Mass Index
|
31.3 kg/m^2
STANDARD_DEVIATION 10.2 • n=93 Participants
|
28.2 kg/m^2
STANDARD_DEVIATION 5.6 • n=4 Participants
|
29.7 kg/m^2
STANDARD_DEVIATION 8.2 • n=27 Participants
|
|
Sexually Active
|
9 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Prior participation in vaginal film studies
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Approximately 30 minutesPopulation: All participants who attempted insertion of both vaginal film products which included the entire cohort of 30 enrolled participants.
Number of participants that successfully insert each vaginal film defined as the film location being completely inside the vagina upon visual assessment by a clinician
Outcome measures
| Measure |
High Eudragit® Film
n=30 Participants
High Eudragit® Content Vaginal Film: High (12.8%) Eudragit® Content Vaginal Film
|
Low Eudragit® Film
n=30 Participants
Low Eudragit® Content Vaginal Film: Low (6.4%) Eudragit® Content Vaginal Film
|
|---|---|---|
|
Number of Participants That Successfully Insert Vaginal Film
Successful Insertion
|
8 Participants
|
8 Participants
|
|
Number of Participants That Successfully Insert Vaginal Film
Unsuccessful insertion
|
22 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Approximately 30 minutesParticipants that report that self-insertion of the placebo vaginal film was not difficult at all as assessed on a Likert scale from 1 (not difficult at all) to 4 (very difficult)
Outcome measures
| Measure |
High Eudragit® Film
n=30 Participants
High Eudragit® Content Vaginal Film: High (12.8%) Eudragit® Content Vaginal Film
|
Low Eudragit® Film
n=30 Participants
Low Eudragit® Content Vaginal Film: Low (6.4%) Eudragit® Content Vaginal Film
|
|---|---|---|
|
Number of Participants That Report Self-Insertion of Vaginal Film Was Easy
Not Difficult To Insert
|
11 Participants
|
8 Participants
|
|
Number of Participants That Report Self-Insertion of Vaginal Film Was Easy
At Least Some Difficulty Inserting Film
|
19 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Approximately 1 hourPopulation: All participants that attempted insertion of both vaginal film products; this included the entire cohort of 30 enrolled.
Number of participants that report that they would prefer to use the high Eudragit® content vaginal film over the low Eudragit® content vaginal film. This outcome was analyzed by order of film product use (high then low vs low then high) as this may influence product preference.
Outcome measures
| Measure |
High Eudragit® Film
n=15 Participants
High Eudragit® Content Vaginal Film: High (12.8%) Eudragit® Content Vaginal Film
|
Low Eudragit® Film
n=15 Participants
Low Eudragit® Content Vaginal Film: Low (6.4%) Eudragit® Content Vaginal Film
|
|---|---|---|
|
Number of Participants That Prefer the High Over the Low Eudragit® Content Vaginal Film
Preferred High Eudragit® Film
|
5 Participants
|
9 Participants
|
|
Number of Participants That Prefer the High Over the Low Eudragit® Content Vaginal Film
Preferred Low Eudragit® Film
|
5 Participants
|
2 Participants
|
|
Number of Participants That Prefer the High Over the Low Eudragit® Content Vaginal Film
No Preference
|
5 Participants
|
4 Participants
|
Adverse Events
High Eudragit® Film, Then Low Eudragit® Film
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Eudragit® Film, Then High Eudragit® Film
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Leslie Meyn
University of Pittsburgh Medical School
Phone: 412-641-4233
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place