Postmenopausal Pessary Users: Estrogen Versus Trimosan

Phase 4

Terminated

• Conditions: Vaginosis; Vaginosis, Bacterial; Vaginal Discharge
• Interventions: Drug: Estrogen vaginal cream; Drug: Trimo-San vaginal gel

• Registration Number: NCT03943823
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-07
• Study First Submitted: 2019-05-07
• Study First Submitted QC: 2019-05-07
• Study First Posted: 2019-05-09
• Primary Completion: 2021-03-08
• Study Completion: 2021-04-08
• Results First Submitted: 2023-02-06
• Results First Submitted QC: 2023-02-06
• Status Verified: 2023-03
• Results First Posted: 2023-03-01
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Estrogen vaginal cream	Estrogen vaginal cream	-
Trimo-San vaginal gel	Trimo-San vaginal gel	-

Primary Outcome Measures

Name	Time	Method
Vaginal pH as Measured by pH Strips	3 months	pH is measured on a scale of 0 to 14, with lower values indicating greater acidity and higher values indicating greater alkalinity.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire	3 months

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States