Postmenopausal Pessary Users: Estrogen Versus Trimosan

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-07

Study Completion Date

2021-04-08

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.

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Detailed Description

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Conditions

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Vaginosis Vaginosis, Bacterial Vaginal Discharge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Estrogen vaginal cream

Group Type ACTIVE_COMPARATOR

Estrogen vaginal cream

Intervention Type DRUG

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 gel

Group Type ACTIVE_COMPARATOR

Trimo-San vaginal gel

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Trimo-San vaginal gel

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

Intervention Type DRUG

Other Intervention Names

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Estrace Cream Premarin Cream Trimo-San

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

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No