Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029757
Status:
COMPLETED
Last Update Posted:
2005-11-07
First Post:
2002-01-22
Brief Title:
Buccal Estrogen in Toothpaste Study Systemic Absorption of Estradiol When Administered Mixed With Toothpaste in Postmenopausal or Surgically Menopausal Women
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
Buccal Estrogen in Toothpaste Study Systemic Absorption of Estradiol When Administered Mixed With Toothpaste in Postmenopausal or Surgically Menopausal Women
Status:
COMPLETED
Status Verified Date:
2003-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background The use of estrogen in postmenopausal or surgically menopausal women is a common practice Compliance is problematic in that estimates show only 13 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 Aims1 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
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 Aims1 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
Detailed 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 05 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: