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NCT00029757 · ClinicalTrials.gov registry record · NA
Buccal Estrogen in Toothpaste Study: Systemic Absorption of Estradiol When Administered Mixed With Toothpaste in Postmenopausal or Surgically Menopausal Women
A NA study of Menopause and Postmenopause, sponsored by National Center for Research Resources (NCRR).
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT00029757 is a NA study of Menopause and Postmenopause that has completed, run by National Center for Research Resources (NCRR). The registered enrollment target is 15 participants, below the 9,394-participant average among 54 other Menopause trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00029757, a NA study of Menopause and Postmenopause, has completed, sponsored by National Center for Research Resources (NCRR).
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Estrogen
Study Locations (1)
Texas
- University of Texas--Houston Medical School - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00029757
The ClinicalTrials.gov registry entry for NCT00029757 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 9,394-participant average among 54 other Menopause trials with a reported enrollment target (100% lower). The listed sponsor is National Center for Research Resources (NCRR), which has 94 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Menopause appearing as the primary indexed condition, and to 1 intervention - of which Estrogen is the first listed.
NCT00029757 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00029757 about?
NCT00029757 is a clinical study titled "Buccal Estrogen in Toothpaste Study: Systemic Absorption of Estradiol When Administered Mixed With Toothpaste in Postmenopausal or Surgically Menopausal Women". 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 re...
What is the current status of trial NCT00029757?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants.
What conditions does trial NCT00029757 study?
This clinical trial studies the following conditions: Menopause, Postmenopause.
What interventions are being tested in trial NCT00029757?
The interventions under investigation include: Estrogen (DRUG).
Who is sponsoring clinical trial NCT00029757?
This trial is sponsored by National Center for Research Resources (NCRR), which has 94 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00029757 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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