Trial Outcomes & Findings for Postmenopausal Pessary Users: Estrogen Versus Trimosan (NCT NCT03943823)
NCT ID: NCT03943823
Last Updated: 2023-03-08
Results Overview
pH is measured on a scale of 0 to 14, with lower values indicating greater acidity and higher values indicating greater alkalinity.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
4 participants
Primary outcome timeframe
baseline
Results posted on
2023-03-08
Participant Flow
Participant milestones
| Measure |
Estrogen Vaginal Cream
Estrogen vaginal cream: Either Premarin or Estrace cream will be used (dependent on patient's insurance). Premarin 1 gram every night for the first 7 days, then 0.5 grams twice weekly. Estrace cream 2 grams daily for first 7 days, then 1 gram twice-weekly.
|
Trimo-San Vaginal Gel
Trimo-San vaginal gel: Half applicator for three times a week for 1st week, then half applicator for 2 times a week.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Postmenopausal Pessary Users: Estrogen Versus Trimosan
Baseline characteristics by cohort
| Measure |
Estrogen Vaginal Cream
n=2 Participants
Estrogen vaginal cream: Either Premarin or Estrace cream will be used (dependent on patient's insurance). Premarin 1 gram every night for the first 7 days, then 0.5 grams twice weekly. Estrace cream 2 grams daily for first 7 days, then 1 gram twice-weekly.
|
Trimo-San Vaginal Gel
n=2 Participants
Trimo-San vaginal gel: Half applicator for three times a week for 1st week, then half applicator for 2 times a week.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
age 60 to 75
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baselinepH is measured on a scale of 0 to 14, with lower values indicating greater acidity and higher values indicating greater alkalinity.
Outcome measures
| Measure |
Estrogen Vaginal Cream
n=2 Participants
Estrogen vaginal cream: Either Premarin or Estrace cream will be used (dependent on patient's insurance). Premarin 1 gram every night for the first 7 days, then 0.5 grams twice weekly. Estrace cream 2 grams daily for first 7 days, then 1 gram twice-weekly.
|
Trimo-San Vaginal Gel
n=2 Participants
Trimo-San vaginal gel: Half applicator for three times a week for 1st week, then half applicator for 2 times a week.
|
|---|---|---|
|
Vaginal pH as Measured by pH Strips
|
4.5 pH
Standard Deviation 0.70
|
6 pH
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 3 monthspH is measured on a scale of 0 to 14, with lower values indicating greater acidity and higher values indicating greater alkalinity.
Outcome measures
| Measure |
Estrogen Vaginal Cream
n=2 Participants
Estrogen vaginal cream: Either Premarin or Estrace cream will be used (dependent on patient's insurance). Premarin 1 gram every night for the first 7 days, then 0.5 grams twice weekly. Estrace cream 2 grams daily for first 7 days, then 1 gram twice-weekly.
|
Trimo-San Vaginal Gel
n=2 Participants
Trimo-San vaginal gel: Half applicator for three times a week for 1st week, then half applicator for 2 times a week.
|
|---|---|---|
|
Vaginal pH as Measured by pH Strips
|
4.25 pH
Standard Deviation .35
|
5 pH
Standard Deviation .70
|
SECONDARY outcome
Timeframe: baselineOutcome measures
| Measure |
Estrogen Vaginal Cream
n=2 Participants
Estrogen vaginal cream: Either Premarin or Estrace cream will be used (dependent on patient's insurance). Premarin 1 gram every night for the first 7 days, then 0.5 grams twice weekly. Estrace cream 2 grams daily for first 7 days, then 1 gram twice-weekly.
|
Trimo-San Vaginal Gel
n=2 Participants
Trimo-San vaginal gel: Half applicator for three times a week for 1st week, then half applicator for 2 times a week.
|
|---|---|---|
|
Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 monthsOutcome measures
| Measure |
Estrogen Vaginal Cream
n=2 Participants
Estrogen vaginal cream: Either Premarin or Estrace cream will be used (dependent on patient's insurance). Premarin 1 gram every night for the first 7 days, then 0.5 grams twice weekly. Estrace cream 2 grams daily for first 7 days, then 1 gram twice-weekly.
|
Trimo-San Vaginal Gel
n=2 Participants
Trimo-San vaginal gel: Half applicator for three times a week for 1st week, then half applicator for 2 times a week.
|
|---|---|---|
|
Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baselinePresence of vaginitis infection will be assessed with an Affirm test, which probes for Gardnerella vaginalis, Candida albicans, and Trichomonas vaginalis.
Outcome measures
| Measure |
Estrogen Vaginal Cream
n=2 Participants
Estrogen vaginal cream: Either Premarin or Estrace cream will be used (dependent on patient's insurance). Premarin 1 gram every night for the first 7 days, then 0.5 grams twice weekly. Estrace cream 2 grams daily for first 7 days, then 1 gram twice-weekly.
|
Trimo-San Vaginal Gel
n=2 Participants
Trimo-San vaginal gel: Half applicator for three times a week for 1st week, then half applicator for 2 times a week.
|
|---|---|---|
|
Number of Participants With Vaginitis Infection
Gardnerella vaginalis
|
1 Participants
|
2 Participants
|
|
Number of Participants With Vaginitis Infection
Candida albicans
|
2 Participants
|
0 Participants
|
|
Number of Participants With Vaginitis Infection
Trichomonas vaginalis
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPresence of vaginitis infection will be assessed with an Affirm test, which probes for Gardnerella vaginalis, Candida albicans, and Trichomonas vaginalis.
Outcome measures
| Measure |
Estrogen Vaginal Cream
n=2 Participants
Estrogen vaginal cream: Either Premarin or Estrace cream will be used (dependent on patient's insurance). Premarin 1 gram every night for the first 7 days, then 0.5 grams twice weekly. Estrace cream 2 grams daily for first 7 days, then 1 gram twice-weekly.
|
Trimo-San Vaginal Gel
n=2 Participants
Trimo-San vaginal gel: Half applicator for three times a week for 1st week, then half applicator for 2 times a week.
|
|---|---|---|
|
Number of Participants With Vaginitis Infection
Gardnerella vaginalis
|
2 Participants
|
2 Participants
|
|
Number of Participants With Vaginitis Infection
Candida albicans
|
2 Participants
|
0 Participants
|
|
Number of Participants With Vaginitis Infection
Trichomonas vaginalis
|
0 Participants
|
0 Participants
|
Adverse Events
Estrogen Vaginal Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Trimo-San Vaginal Gel
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
Sunbola Ashimi, PhD
The University of Texas Health Science Center at Houston
Phone: 713-500-6410
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place