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Postmenopausal Pessary Users: Estrogen Versus Trimosan

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Recruiting
CT.gov ID
NCT03943823
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
35.8
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Estrogen vaginal cream
  • Drug: Trimo-San vaginal gel
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Postmenopausal Pessary Users: Estrogen Versus Trimosan
Actual Study Start Date :
May 7, 2019
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Vaginal pH as measured by pH strips [baseline]

    2. Vaginal pH as measured by pH strips [3 months]

    Secondary Outcome Measures

    1. Vaginal Symptoms as assessed by a vaginitis questionnaire [baseline]

    2. Vaginal Symptoms as assessed by a vaginitis questionnaire [3 months]

    3. Number of participants with vaginosis infection [baseline]

      Vaginosis infection will be diagnosed either by gram staining or an Affirm bacterial vaginosis (BV) test, which probes for DNA of microorganisms that cause BV.

    4. Number of participants with vaginosis infection [3 months]

      Vaginosis infection will be diagnosed either by gram staining or by an Affirm bacterial vaginosis (BV) test, which probes for DNA of microorganisms that cause BV.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

    Sponsors and Collaborators

    • The University of Texas Health Science Center, Houston

    Investigators

    • Principal Investigator: Gazala Siddiqui, MD, The University of Texas Health Science Center, Houston

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gazala Siddiqui, Assistant Professor, The University of Texas Health Science Center, Houston
    ClinicalTrials.gov Identifier:
    NCT03943823
    Other Study ID Numbers:
    • HSC-MS-15-0337
    First Posted:
    May 9, 2019
    Last Update Posted:
    Nov 12, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Gazala Siddiqui, Assistant Professor, The University of Texas Health Science Center, Houston
    Pessary
    Vaginal pH
    Additional relevant MeSH terms:
    Vaginosis, Bacterial
    Vaginal Diseases
    Vaginal Discharge
    Estrogens

    Study Results

    No Results Posted as of Nov 12, 2020