Menopause Clinical Trial
Official title:
Buccal Estrogen in Toothpaste Study: Systemic Absorption of Estradiol When Administered Mixed With Toothpaste in Postmenopausal or Surgically Menopausal Women
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 |
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.
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Texas--Houston Medical School | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
National Center for Research Resources (NCRR) |
United States,
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