Back to resultsPostmenopausal Pessary Users: Estrogen Versus Trimosan
Primary Purpose
Vaginosis, Vaginosis, Bacterial, Vaginal Discharge
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Estrogen vaginal cream
Trimo-San vaginal gel
Sponsored by
About this trial
This is an interventional treatment trial for Vaginosis focused on measuring Pessary, Vaginal pH
Eligibility Criteria
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
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Estrogen vaginal cream
Trimo-San vaginal gel
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire
Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire
Full Information
NCT ID
NCT03943823
First Posted
May 7, 2019
Last Updated
March 6, 2023
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT03943823
Brief Title
Postmenopausal Pessary Users: Estrogen Versus Trimosan
Official Title
Postmenopausal Pessary Users: Estrogen Versus Trimosan
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Difficulties in recruiting and retaining patients due to the COVID pandemic; lack of availability of study drug trimosan; lack of study personnel
Study Start Date
May 7, 2019 (Actual)
Primary Completion Date
March 8, 2021 (Actual)
Study Completion Date
April 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginosis, Vaginosis, Bacterial, Vaginal Discharge
Keywords
Pessary, Vaginal pH
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Estrogen vaginal cream
Arm Type
Active Comparator
Arm Title
Trimo-San vaginal gel
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Estrogen vaginal cream
Other Intervention Name(s)
Estrace Cream, Premarin Cream
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Trimo-San vaginal gel
Other Intervention Name(s)
Trimo-San
Intervention Description
Half applicator for three times a week for 1st week, then half applicator for 2 times a week.
Primary Outcome Measure Information:
Title
Vaginal pH as Measured by pH Strips
Description
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
Title
Vaginal pH as Measured by pH Strips
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire
Time Frame
baseline
Title
Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Number of Participants With Vaginitis Infection
Description
Presence of vaginitis infection will be assessed with an Affirm test, which probes for Gardnerella vaginalis, Candida albicans, and Trichomonas vaginalis.
Time Frame
baseline
Title
Number of Participants With Vaginitis Infection
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gazala Siddiqui, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Postmenopausal Pessary Users: Estrogen Versus Trimosan
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