Vaginosis, Bacterial Clinical Trial
Official title:
Postmenopausal Pessary Users: Estrogen Versus Trimosan
Verified date | March 2023 |
Source | The University of Texas Health Science Center, Houston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
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 |
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---|---|---|---|
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