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Buccal Estrogen in Toothpaste Study: Systemic Absorption of Estradiol When Administered Mixed With Toothpaste in Postmenopausal or Surgically Menopausal Women
This study has been completed.
First Received: January 22, 2002   Last Updated: November 4, 2005   History of Changes
Sponsored by: National Center for Research Resources (NCRR)
Information provided by: National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier: NCT00029757
  Purpose

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.


Condition Intervention
Menopause
Postmenopause
Drug: Estrogen

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title: Buccal Estrogen in Toothpaste Study: Systemic Absorption of Estradiol When Administered Mixed With Toothpaste in Postmenopausal or Surgically Menopausal Women

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 15
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 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

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Postmenopausal women or surgically menopausal women, not on hormone replacement therapy for at least 3 weeks

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00029757

Locations
United States, Texas
University of Texas--Houston Medical School
Houston, Texas, United States, 77030
Sponsors and Collaborators
  More Information

No publications provided

Study ID Numbers: NCRR-M01RR02558-1056
Study First Received: January 22, 2002
Last Updated: November 4, 2005
ClinicalTrials.gov Identifier: NCT00029757     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):
Surgical menopause

Study placed in the following topic categories:
Estrogens
Hormone Antagonists
Estradiol 3-benzoate
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Hormones
Estradiol
Menopause

Additional relevant MeSH terms:
Estrogens
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009