Vaginal Discharge, Vaginosis, Vaginosis, Bacterial
Conditions
Keywords
Pessary, Vaginal pH
Brief summary
The purpose of the study is to compare vaginally applied estrogen with the vaginal gel trimosan for their effects on vaginal pH and vaginal symptoms in postmenopausal pessary users.
Interventions
DRUGEstrogen 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.
DRUGTrimo-San vaginal gel
Half applicator for three times a week for 1st week, then half applicator for 2 times a week.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Postmenopausal female pessary user (ring with support pessaries only). Postmenopausal will be defined as: amenorrhea for a year or 3 months after surgical bilateral salpingo-oophorectomy * Is a new pessary user, or has not had a pessary for a year
Exclusion criteria
* Pregnancy * Persistent Bacterial Vaginosis infection in the first two clinic encounters * Currently on hormone replacement therapy * Previously on hormone replacement therapy in the past 6 months * Currently on antibiotics * Patients with existing vaginal erosions/ulcerations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal pH as Measured by pH Strips | baseline | pH is measured on a scale of 0 to 14, with lower values indicating greater acidity and higher values indicating greater alkalinity. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire | baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Vaginitis Infection | baseline | Presence of vaginitis infection will be assessed with an Affirm test, which probes for Gardnerella vaginalis, Candida albicans, and Trichomonas vaginalis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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. | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | Estrogen Vaginal Cream | Total | Trimo-San Vaginal Gel |
|---|---|---|---|
| Age, Customized age 60 to 75 | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
Vaginal pH as Measured by pH Strips
pH is measured on a scale of 0 to 14, with lower values indicating greater acidity and higher values indicating greater alkalinity.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estrogen Vaginal Cream | Vaginal pH as Measured by pH Strips | 4.5 pH | Standard Deviation 0.7 |
| Trimo-San Vaginal Gel | Vaginal pH as Measured by pH Strips | 6 pH | Standard Deviation 0 |
Primary
Vaginal pH as Measured by pH Strips
pH is measured on a scale of 0 to 14, with lower values indicating greater acidity and higher values indicating greater alkalinity.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Estrogen Vaginal Cream | Vaginal pH as Measured by pH Strips | 4.25 pH | Standard Deviation 0.35 |
| Trimo-San Vaginal Gel | Vaginal pH as Measured by pH Strips | 5 pH | Standard Deviation 0.7 |
Secondary
Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire
Time frame: baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Estrogen Vaginal Cream | Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire | 1 Participants |
| Trimo-San Vaginal Gel | Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire | 0 Participants |
Secondary
Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Estrogen Vaginal Cream | Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire | 1 Participants |
| Trimo-San Vaginal Gel | Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire | 0 Participants |
Other Pre-specified
Number of Participants With Vaginitis Infection
Presence of vaginitis infection will be assessed with an Affirm test, which probes for Gardnerella vaginalis, Candida albicans, and Trichomonas vaginalis.
Time frame: baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estrogen Vaginal Cream | Number of Participants With Vaginitis Infection | Gardnerella vaginalis | 1 Participants |
| Estrogen Vaginal Cream | Number of Participants With Vaginitis Infection | Candida albicans | 2 Participants |
| Estrogen Vaginal Cream | Number of Participants With Vaginitis Infection | Trichomonas vaginalis | 0 Participants |
| Trimo-San Vaginal Gel | Number of Participants With Vaginitis Infection | Gardnerella vaginalis | 2 Participants |
| Trimo-San Vaginal Gel | Number of Participants With Vaginitis Infection | Candida albicans | 0 Participants |
| Trimo-San Vaginal Gel | Number of Participants With Vaginitis Infection | Trichomonas vaginalis | 0 Participants |
Other Pre-specified
Number of Participants With Vaginitis Infection
Presence of vaginitis infection will be assessed with an Affirm test, which probes for Gardnerella vaginalis, Candida albicans, and Trichomonas vaginalis.
Time frame: 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Estrogen Vaginal Cream | Number of Participants With Vaginitis Infection | Gardnerella vaginalis | 2 Participants |
| Estrogen Vaginal Cream | Number of Participants With Vaginitis Infection | Candida albicans | 2 Participants |
| Estrogen Vaginal Cream | Number of Participants With Vaginitis Infection | Trichomonas vaginalis | 0 Participants |
| Trimo-San Vaginal Gel | Number of Participants With Vaginitis Infection | Gardnerella vaginalis | 2 Participants |
| Trimo-San Vaginal Gel | Number of Participants With Vaginitis Infection | Candida albicans | 0 Participants |
| Trimo-San Vaginal Gel | Number of Participants With Vaginitis Infection | Trichomonas vaginalis | 0 Participants |