Postmenopausal Pessary Users: Estrogen Versus Trimosan

Phase 4TerminatedNCT03943823

The University of Texas Health Science Center, Houston4 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vaginosis Vaginosis, Bacterial Vaginal Discharge

Interventions

Estrogen vaginal creamDRUG

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.

Trimo-San vaginal gelDRUG

Half applicator for three times a week for 1st week, then half applicator for 2 times a week.

Eligibility

Sex: FEMALEMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire

Time frame: baseline

Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire

Time frame: 3 months

Data from ClinicalTrials.gov

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