- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03943823
Postmenopausal Pessary Users: Estrogen Versus Trimosan
February 6, 2023 updated by: Gazala Siddiqui, The University of Texas Health Science Center, Houston
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Carol Robazetti, MD
- Phone Number: 713-500-6382
- Email: sonia.c.robazetti@uth.tmc.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
Other Names:
|
Active Comparator: Trimo-San vaginal gel
|
Half applicator for three times a week for 1st week, then half applicator for 2 times a week.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vaginal pH as Measured by pH Strips
Time Frame: baseline
|
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
Time Frame: 3 months
|
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 |
Time Frame |
---|---|
Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire
Time Frame: baseline
|
baseline
|
Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire
Time Frame: 3 months
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Vaginitis Infection
Time Frame: baseline
|
Presence of vaginitis infection will be assessed with an Affirm test, which probes for Gardnerella vaginalis, Candida albicans, and Trichomonas vaginalis.
|
baseline
|
Number of Participants With Vaginitis Infection
Time Frame: 3 months
|
Presence of vaginitis infection will be assessed with an Affirm test, which probes for Gardnerella vaginalis, Candida albicans, and Trichomonas vaginalis.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gazala Siddiqui, MD, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 7, 2019
Primary Completion (Actual)
March 8, 2021
Study Completion (Actual)
April 8, 2021
Study Registration Dates
First Submitted
May 7, 2019
First Submitted That Met QC Criteria
May 7, 2019
First Posted (Actual)
May 9, 2019
Study Record Updates
Last Update Posted (Actual)
March 1, 2023
Last Update Submitted That Met QC Criteria
February 6, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-15-0337
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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