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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Estrogen vaginal cream
  • Drug: 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
  • Drug: 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

More Details

Status
Terminated
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.