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Difficulties in recruiting and retaining patients due to the COVID pandemic; lack of availability of study drug trimosan; lack of study personnel
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Estrogen vaginal cream | Active Comparator |
| |
| Trimo-San vaginal gel | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estrogen vaginal cream | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Participants With Vaginitis Infection |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gazala Siddiqui, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Estrogen Vaginal Cream | 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. |
| FG001 | Trimo-San Vaginal Gel | Trimo-San vaginal gel: Half applicator for three times a week for 1st week, then half applicator for 2 times a week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Estrogen Vaginal Cream | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | pH | baseline |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Estrogen Vaginal Cream | 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. |
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Early termination as a result of discontinuation of in-person research due to COVID-19 pandemic, as well as unavailability of study drug.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sunbola Ashimi, PhD | The University of Texas Health Science Center at Houston | 713-500-6410 | Sunbola.S.Ashimi@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 28, 2015 | Jan 27, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D016585 | Vaginosis, Bacterial |
| D019522 | Vaginal Discharge |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| Trimo-San vaginal gel | Drug | Half applicator for three times a week for 1st week, then half applicator for 2 times a week. |
|
|
Presence of vaginitis infection will be assessed with an Affirm test, which probes for Gardnerella vaginalis, Candida albicans, and Trichomonas vaginalis. |
| 3 months |
| Trimo-San Vaginal Gel |
Trimo-San vaginal gel: Half applicator for three times a week for 1st week, then half applicator for 2 times a week. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | pH | 3 months |
|
|
|
| Secondary | Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire | Posted | Count of Participants | Participants | baseline |
|
|
|
| Secondary | Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Other Pre-specified | 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. | Posted | Count of Participants | Participants | baseline |
|
|
|
| Other Pre-specified | 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. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Trimo-San Vaginal Gel | Trimo-San vaginal gel: Half applicator for three times a week for 1st week, then half applicator for 2 times a week. | 0 | 2 | 0 | 2 | 0 | 2 |
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| D000091662 | Genital Diseases |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
| Trichomonas vaginalis |
|
| Trichomonas vaginalis |
|