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Buccal estrogen in toothpaste study: Systemic absorption of estradiol when administered mixed with toothpaste in postmenopausal or surgically menopausal women Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Buccal estrogen in toothpaste study: Systemic absorption of estradiol when administered mixed with toothpaste in postmenopausal or surgically menopausal women conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Buccal estrogen in toothpaste study: Systemic absorption of estradiol when administered mixed with toothpaste in postmenopausal or surgically menopausal women Clinical research trials and Buccal estrogen in toothpaste study: Systemic absorption of estradiol when administered mixed with toothpaste in postmenopausal or surgically menopausal women health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Buccal estrogen in toothpaste study: Systemic absorption of estradiol when administered mixed with toothpaste in postmenopausal or surgically menopausal women. Buccal estrogen in toothpaste study: Systemic absorption of estradiol when administered mixed with toothpaste in postmenopausal or surgically menopausal women Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Buccal estrogen in toothpaste study: Systemic absorption of estradiol when administered mixed with toothpaste in postmenopausal or surgically menopausal women clinical trial. Human subjects often get the best healthcare possible for their Buccal estrogen in toothpaste study: Systemic absorption of estradiol when administered mixed with toothpaste in postmenopausal or surgically menopausal women condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Buccal estrogen in toothpaste study: Systemic absorption of estradiol when administered mixed with toothpaste in postmenopausal or surgically menopausal women  Buccal estrogen in toothpaste study: Systemic absorption of estradiol when administered mixed with toothpaste in postmenopausal or surgically menopausal women
Buccal estrogen in toothpaste study: Systemic absorption of estradiol when administered mixed with toothpaste in postmenopausal or surgically menopausal women
For Condition: Menopause,Postmenopause
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) ,
Synopsis: Background: The use of estrogen in postmenopausal (or surgically menopausal) women is a common practice. Compliance is problematic in that estimates show only 1/3 of women use hormone replacement therapy (HRT) and only 30% are compliant. Estrogen has many documented benefits including symptomatic relief of hot flashes, improvement of the dry vagina and dysparunia. Estrogen has been found to improve bone mineral density and increase the high- density lipoprotein portion of a cholesterol panel. To improve compliance and to provide an alternate method of delivery, we propose the use of estrogen which is admixed in toothpaste and propose to study the absorption, rate of build-up and rate of decline. Hypothesis: Estrogen can potentially be absorbed systemically when toothpaste is admixed with estradiol and is applied in a timed, consistent fashion to postmenopausal or surgically postmenopausal women, not on HRT. Absorption takes place across the buccal mucosa. Specific Aims:1) To estimate the systemic absorption of estrogen from daily use of estrogen containing toothpaste. 2) To estimate the rate of build-up of serum estrogen levels based upon daily use of toothpaste containing estrogen for eight days. 3) To estimate the rate of decline in serum estrogen levels when the use of estrogen containing toothpaste is discontinued for a week.
Details: Methods: Fifteen women ages 35-75 who are menopausal or surgically menopausal will be identified, with exclusion based on estrogen contraindications. Subjects will have blood samples taken before, during and after an eight-day course of once-daily toothpaste that is admixed with 0.5 mg estradiol. Toothpaste shall meet strict quality control standards and instructions for uniform tooth brushing shall be provided. Serum estradiol will be determined from the samples obtained. Statistical analysis shall address absorption by comparing baseline estradiol measurements with those a few hours after use. The rate of build-up will be assessed by comparing the post-use levels of estradiol at the start of a week and at the end of the week. After a week off the estrogen, the rate of decline in serum estradiol will be calculated.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Minimum Age/Maximum Age: 35 Years/75 Years
Genders: Female
Protocol Entry Criteria: Postmenopausal women or surgically menopausal women, not on hormone replacement therapy for at least 3 weeks
Total Enrollment: 15
Location and Contact Information:
University of Texas--Houston Medical School
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: NCRR-M01RR02558-1056;
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029757
Other Menopause Studies:
1. Women's Healthy Lifestyle Project: Cardiovascular Risk Factors and Menopause
2. Thrombotic, Inflammatory & Gene Markers of CVD in Women
3. Lifestyle Management for Women with CHD and NIDDM
4. Women's Health Trial: Feasibility Study in Minority Populations
5. Women's Angiographic Vitamin and Estrogen Trial (WAVE)
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Buccal estrogen in toothpaste study: Systemic absorption of estradiol when administered mixed with toothpaste in postmenopausal or surgically menopausal women
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