DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2007 by Centre Hospitalier Universitaire de Québec, CHU de Québec.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Centre Hospitalier Universitaire de Québec, CHU de Québec

ClinicalTrials.gov Identifier:

NCT00429806

First received: January 31, 2007

Last updated: NA

Last verified: January 2007

History: No changes posted

Purpose

The purpose of the study is to evaluate the systemic bioavailability of DHEA and its metabolites and the pharmacokinetics of vaginal suppositories at four different DHEA concentration.

Condition	Intervention	Phase
Vaginal Atrophy	Drug: DHEA	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy-Phase I Randomized,Placebo-Controlled, Double-Blind Study.

Resource links provided by NLM:

MedlinePlus related topics: Menopause

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:

The evaluation of the systemic bioavailability of DHEA and its metabolites.
The pharmacokinetics of vaginal suppositories at four different DHEA concentrations.

Secondary Outcome Measures:

The safety and tolerance of the suppositories.

Estimated Enrollment:	40
Study Start Date:	December 2006
Estimated Study Completion Date:	January 2007

Detailed Description:

Humans, are unique among animal species in having adrenals that secrete large amounts of the inactive precursor steroids dehydroepiandrosterone (DHEA) and especially its sulfate DHEA-S. The marked reduction in the formation of DHEA-S by the adrenals during aging results in a dramatic fall in the formation of androgens and estrogens in peripheral target tissues, a situation that has been proposed to be associated with age-related diseases including skin atrophy, insulin resistance and obesity. Much attention has been given to the benefits of DHEA administered to postmenopausal women, especially on the bone, skin, vagina and well being after oral as well as percutaneous administration of the precursor steroid.

Therefore, this study proposes to evaluate the systemic bioavailability and the effectiveness of 1.3 mL vaginal suppositories of DHEA at 4 different concentrations (0.0%, 0.5%, 1.0% et 1.8%) following 1 week administration of vaginal suppositories in post-menopausal women with vaginal atrophy. This is a phase I, randomized, placebo-controlled, double-blind study.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postmenopausal women,
Experiencing one symptom of vaginal atrophy (vaginal dryness, vaginal and/or vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity or vaginal bleeding associated with sexual activity,
Women having a low maturation index and a vaginal pH above 5,
Endometrial thickness of 4 mm or less at transvaginal ultrasonography,
Body weight within 18.5 and 32.0 according to body mass index.

Exclusion Criteria:

Undiagnosed abnormal genital bleeding,
Active or history of thromboembolic disease,
Significant metabolic or endocrine disease,
Significant complication on previous hormonal therapy,
Use of hormonal implants within 6 months prior to study entry,
Use of oral estrogen, progestin or DHEA in the 8 weeks prior to baseline,
Use of natural (phytoestrogens) or herbal products in the 2 weeks prior to baseline,
Chronic use of corticosteroids,
Hypertension not controlled by standard therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429806

Locations

Canada
Clinique des traitements hormonaux CHUL Research Center
Quebec, Canada, G1V 4G2

Sponsors and Collaborators

Centre Hospitalier Universitaire de Québec, CHU de Québec

Investigators

Study Chair:	Fernand Labrie, MD, Ph D	CHUL Research Center Director
Principal Investigator:	Cusan Leonello, MD Ph D	CHUL Research Center

More Information

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ClinicalTrials.gov Identifier:	NCT00429806 History of Changes
Other Study ID Numbers:	ERC-213
Study First Received:	January 31, 2007
Last Updated:	January 31, 2007
Health Authority:	Canada: Health Canada

Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Vaginal atrophy

Additional relevant MeSH terms:

Atrophy
Pathological Conditions, Anatomical
Dehydroepiandrosterone
Adjuvants, Immunologic

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013

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