NCT03943823

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

May 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2021

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

March 1, 2023

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

May 7, 2019

Results QC Date

February 6, 2023

Last Update Submit

March 6, 2023

Conditions

VaginosisVaginosis, BacterialVaginal Discharge

Keywords

PessaryVaginal pH

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    3 months

Secondary Outcomes (2)

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

    baseline

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

    3 months

Other Outcomes (2)

  • Number of Participants With Vaginitis Infection

    baseline

  • Number of Participants With Vaginitis Infection

    3 months

Study Arms (2)

Estrogen vaginal cream

ACTIVE COMPARATOR
Drug: Estrogen vaginal cream

Trimo-San vaginal gel

ACTIVE COMPARATOR
Drug: Trimo-San vaginal gel

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.

Also known as: Estrace Cream, Premarin Cream
Estrogen vaginal cream
Trimo-San vaginal gelDRUG

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

Also known as: Trimo-San
Trimo-San vaginal gel

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Vaginal DiseasesVaginosis, BacterialVaginal Discharge

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesBacterial InfectionsBacterial Infections and MycosesInfectionsVaginitis

Limitations and Caveats

Early termination as a result of discontinuation of in-person research due to COVID-19 pandemic, as well as unavailability of study drug.

Results Point of Contact

Title
Sunbola Ashimi, PhD
Organization
The University of Texas Health Science Center at Houston
Sunbola.S.Ashimi@uth.tmc.edu
713-500-6410

Study Officials

  • Gazala Siddiqui, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 9, 2019

Study Start

May 7, 2019

Primary Completion

March 8, 2021

Study Completion

April 8, 2021

Last Updated

March 8, 2023

Results First Posted

March 1, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)