A Study Evaluating the Effects of Topical Clitoral Estradiol Cream in Post Menopausal Women
NCT ID: NCT02859285
Last Updated: 2020-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2016-04-30
2020-03-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Estradiol vulvar cream
The estradiol cream 0.5 grams will be placed on the clitoris/vestibule every night for 2 weeks, then 3 times a week thereafter on Monday, Wednesday, and Friday, for a total of 12 weeks.
In addition estradiol 10mcg tablet will be placed in the vaginal every night for 2 weeks, then 2x a week on Tuesday and Thursday, for a total of 12 weeks.
Estradiol vulvar cream
Placebo cream
The placebo cream 0.5 grams will be placed on the clitoris/vestibule every night for 2 weeks, then 3 times a week thereafter on Monday, Wednesday, and Friday, for a total of 12 weeks.
In addition estradiol 10mcg tablet will be placed in the vaginal every night for 2 weeks, then 2x a week on Tuesday and Thursday, for a total of 12 weeks.
Placebo vulvar cream
Interventions
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Placebo vulvar cream
Estradiol vulvar cream
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Uncontrolled diabetes as defined by having a consistent blood sugar level of over 100 mg/dL
* Uncontrolled hypertension as defined by an average systolic blood pressure ≥140 mmHg or an average diastolic blood pressure ≥90 mmHg, among those with hypertension
* Allergic to estradiol
* Contraindications to estradiol such as undiagnosed abnormal genital bleeding; known/suspected or history of breast cancer; known/suspected estrogen-dependent neoplasm; active deep vein thrombosis, pulmonary embolism; active or recent stroke or myocardial infarction; liver dysfunction or disease
* Spanish speaking
18 Years
FEMALE
No
Sponsors
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ProHealth Care, Inc
OTHER
Responsible Party
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Principal Investigators
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Sarit Aschkenazi, MD
Role: STUDY_DIRECTOR
ProHealth Care, Inc
Locations
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Waukesa Memorial Hospital
Waukesha, Wisconsin, United States
Countries
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Other Identifiers
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IRB # 15-18
Identifier Type: -
Identifier Source: org_study_id
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