DHEA Bioavailability Following Administration of Vaginal Suppositories in Post-Menopausal Women With Vaginal Atrophy
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
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.|
- The evaluation of the systemic bioavailability of DHEA and its metabolites.
- The pharmacokinetics of vaginal suppositories at four different DHEA concentrations.
- The safety and tolerance of the suppositories.
|Study Start Date:||December 2006|
|Estimated Study Completion Date:||January 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429806
|Clinique des traitements hormonaux CHUL Research Center|
|Quebec, Canada, G1V 4G2|
|Study Chair:||Fernand Labrie, MD, Ph D||CHUL Research Center Director|
|Principal Investigator:||Cusan Leonello, MD Ph D||CHUL Research Center|