Trial Outcomes & Findings for Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis (NCT NCT01471457)
NCT ID: NCT01471457
Last Updated: 2020-04-22
Results Overview
The primary outcome is the rate of bacterial vaginosis after pessary fitting as measured by OSOM BV blue (Genzyme) and gram stain, measured in women using and women not using Trimo-San gel after pessary fitting, at 3 months, with the denominator being the number of women having a gram stain at the 3 months time point in each group
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
184 participants
Primary outcome timeframe
3 months
Results posted on
2020-04-22
Participant Flow
Participant milestones
| Measure |
Trimo-San Group
Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly
Trimo-San gel: Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly
|
Control Group
Pessary wearers are informed on standard care of pessary, which includes topical estrogen application if they are using. Pessary wearers do not use Trimo-San gel
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
92
|
|
Overall Study
COMPLETED
|
73
|
74
|
|
Overall Study
NOT COMPLETED
|
19
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis
Baseline characteristics by cohort
| Measure |
Trimo-San Group
n=92 Participants
Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly
Trimo-San gel: Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly
|
Control Group
n=92 Participants
Pessary wearers are informed on standard care of pessary, which includes topical estrogen application if they are using. Pessary wearers do not use Trimo-San gel
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 15 • n=99 Participants
|
60 years
STANDARD_DEVIATION 17 • n=107 Participants
|
59 years
STANDARD_DEVIATION 16 • n=206 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
184 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
56 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
6 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
23 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Body Mass Index
|
29 kilograms per square meters
STANDARD_DEVIATION 7.6 • n=99 Participants
|
28 kilograms per square meters
STANDARD_DEVIATION 7.4 • n=107 Participants
|
28 kilograms per square meters
STANDARD_DEVIATION 7.5 • n=206 Participants
|
|
Smoking
Current smoker
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Smoking
Past Smoker
|
26 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Smoking
Non-smoker (never smoker)
|
58 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
116 Participants
n=206 Participants
|
|
Charleston Comorbidity Index
|
0.77 units on a scale
STANDARD_DEVIATION 1.1 • n=99 Participants
|
0.89 units on a scale
STANDARD_DEVIATION 1.8 • n=107 Participants
|
0.82 units on a scale
STANDARD_DEVIATION 1.5 • n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThe primary outcome is the rate of bacterial vaginosis after pessary fitting as measured by OSOM BV blue (Genzyme) and gram stain, measured in women using and women not using Trimo-San gel after pessary fitting, at 3 months, with the denominator being the number of women having a gram stain at the 3 months time point in each group
Outcome measures
| Measure |
Trimo-San Group
n=62 Participants
Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly
Trimo-San gel: Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly
|
Control Group
n=71 Participants
Pessary wearers are informed on standard care of pessary, which includes topical estrogen application if they are using. Pessary wearers do not use Trimo-San gel
|
|---|---|---|
|
Number of Patients With Bacterial Vaginosis at 3 Months
|
15 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 3 monthsVaginal symptoms and effect of vaginal symptoms on pessary wearers measured before and after pessary fitting by questionnaire based on verified vaginal symptoms questionnaire at 3 months, with the denominator being the number of women completing the questionnaire at the 3 months time point in each group
Outcome measures
| Measure |
Trimo-San Group
n=72 Participants
Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly
Trimo-San gel: Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly
|
Control Group
n=75 Participants
Pessary wearers are informed on standard care of pessary, which includes topical estrogen application if they are using. Pessary wearers do not use Trimo-San gel
|
|---|---|---|
|
Participants With Any Bothersome Vaginal Symptom at 3 Months
|
30 Participants
|
24 Participants
|
Adverse Events
Trimo-San Group
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Trimo-San Group
n=92 participants at risk
Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly
Trimo-San gel: Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly
|
Control Group
n=92 participants at risk
Pessary wearers are informed on standard care of pessary, which includes topical estrogen application if they are using. Pessary wearers do not use Trimo-San gel
|
|---|---|---|
|
Reproductive system and breast disorders
Any vaginal symptom attributable possibly to pessary
|
19.6%
18/92 • Number of events 18 • 3 months
Adverse events are worsening of vaginal symptoms since pessary fitting; this could be treatment related or not treatment related Serious adverse events were any recorded events that required hospitalization or were life-threatening, whether related or unrelated to treatment
|
14.1%
13/92 • Number of events 13 • 3 months
Adverse events are worsening of vaginal symptoms since pessary fitting; this could be treatment related or not treatment related Serious adverse events were any recorded events that required hospitalization or were life-threatening, whether related or unrelated to treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place