Postmenopausal Pessary Users: Estrogen Versus Trimosan

Study Overview
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Brief Summary
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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.

Official Title
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Postmenopausal Pessary Users: Estrogen Versus Trimosan

Conditions
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Vaginosis, Vaginosis, Bacterial, Vaginal Discharge

Intervention / Treatment
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* Drug: Estrogen vaginal cream
* Drug: Trimo-San vaginal gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Estrogen vaginal cream<br> | Drug: Estrogen vaginal cream<br>* 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.<br>* Other names: Premarin Cream;|
| Active Comparator: Trimo-San vaginal gel<br> | Drug: Trimo-San vaginal gel<br>* Half applicator for three times a week for 1st week, then half applicator for 2 times a week.<br>* Other names: Trimo-San;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline | 
| 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire |  | baseline | 
| Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pessary, Vaginal pH