Postmenopausal Pessary Users: Estrogen Versus Trimosan

Vaginosis, Bacterial Clinical Trial

Official title:

Postmenopausal Pessary Users: Estrogen Versus Trimosan

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03943823
• Other study ID #: HSC-MS-15-0337
• Status: Terminated
• Phase: Phase 4
• Start date: May 7, 2019
• Est. completion date: April 8, 2021

Study information

• Verified date: March 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 8, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vaginal Discharge
• Vaginal Diseases
• Vaginosis
• Vaginosis, Bacterial

Intervention

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.
• Trimo-San vaginal gel
Half applicator for three times a week for 1st week, then half applicator for 2 times a week.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Vaginitis Infection	Presence of vaginitis infection will be assessed with an Affirm test, which probes for Gardnerella vaginalis, Candida albicans, and Trichomonas vaginalis.	baseline
Other	Number of Participants With Vaginitis Infection	Presence of vaginitis infection will be assessed with an Affirm test, which probes for Gardnerella vaginalis, Candida albicans, and Trichomonas vaginalis.	3 months
Primary	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
Primary	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	Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire		baseline
Secondary	Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire		3 months