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

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

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:
  • Estrace Cream
  • Premarin Cream
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:
  • Trimo-San

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

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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