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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00029757
Other study ID # NCRR-M01RR02558-1056
Secondary ID
Status Completed
Phase N/A
First received January 22, 2002
Last updated November 4, 2005

Study information

Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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 dyspareunia. 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 35 Years to 75 Years
Eligibility Postmenopausal women or surgically menopausal women, not on hormone replacement therapy for at least 3 weeks

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Estrogen


Locations

Country Name City State
United States University of Texas--Houston Medical School Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

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