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Cited by 17Menopause: Health Impacts and TreatmentsHormonal and reproductive studiesEstrogen and related hormone effects

A low dose (6.5 mg) of intravaginal DHEA permits a strictly local action while maintaining all serum estrogens or androgens as well as their metabolites within normal values

Labrie, Fernand, Martel, Céline·2017·Hormone Molecular Biology and Clinical Investigation
DOI 10.1515/hmbci-2016-0042
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Abstract

Objective: Serum concentrations of estradiol (E 2 ) and testosterone (testo) measured by mass spectrometry-based assays should remain below the 95th centile measured at 9.3 pg/mL for E 2 and 0.26 ng/mL for testo in normal postmenopausal women in order to avoid the risk of non-physiological systemic exposure to elevated serum concentrations of these two sex steroids. Methods: Serum E 2 and testo, as well as dehydroepiandrosterone (DHEA) and nine of its other metabolites, were measured at 10 time intervals over 24 h on the first and seventh days of daily intravaginal administration of 0.50% (6.5 mg) DHEA by validated mass spectrometry-based assays. Results: No biologically significant change in the individual serum concentrations of E 2 , testo or DHEA was observed. Most importantly, estrone sulfate (E 1 -S) and the glucuronidated androgen metabolites also remained within normal values, thus confirming the absence of biologically significant systemic exposure in line with intracrinology. Using data from the literature, comparison is made with serum E 2 above normal postmenopausal values following administration of 10-μg E 2 tablets. Conclusion: While the clinical program on vulvovaginal atrophy has shown the efficacy and safety of intravaginal 6.5 mg of DHEA (prasterone), the present data illustrate in detail the serum levels of the individual sex steroids and their metabolites derived from DHEA. The data obtained are in line with the physiology of intracrinology and confirm an action limited to the vagina as the serum concentrations of all sex steroids are maintained within the normal values of menopause, thus protecting the uterus and most likely other tissues.

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  • Intravaginal dehydroepiandrosterone (DHEA) administration causes no evidence of peripheral changes in serum estradiol (E2).

    “They have demonstrated positive impacts on vaginal dryness and other steroid hormone-dependent parameters without any evidence of peripheral changes in serum E2 [94,95].”

    From Endometrial Intracrinology: Oestrogens, Androgens and Endometrial Disorders (2018) · cites this paper as [95]

  • Intravaginal dehydroepiandrosterone (DHEA) administration has positive impacts on vaginal dryness and other steroid hormone-dependent parameters.

    “They have demonstrated positive impacts on vaginal dryness and other steroid hormone-dependent parameters without any evidence of peripheral changes in serum E2 [94,95].”

    From Endometrial Intracrinology: Oestrogens, Androgens and Endometrial Disorders (2018) · cites this paper as [95]

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Authors
Labrie, F., & Martel, C.
Affiliations
  • Endoceutics Inc., 2795 Laurier Blvd, Suite 500, Quebec City, Quebec, G1V 4M7, Canada , Phone: +(418) 653-0055, Fax: +(418) 653-3635
  • Endoceutics Inc., Quebec City, Quebec, G1V 4M7, Canada
Corresponding author
Labrie, Fernand
Venue
Hormone Molecular Biology and Clinical Investigation
Publisher
Walter de Gruyter GmbH
Published
2016-12-20
Volume
29
Issue
2
Pages
39-60
ISSN
  • 1868-1883 (ISSN-L)
  • 1868-1891
DOI
10.1515/hmbci-2016-0042
OpenAlex
W2561425620
Cited by
17
References
88
Citations by year
2026: 1 · 2023: 1 · 2022: 2 · 2021: 2 · 2020: 3 · 2019: 1 · 2018: 5 · 2017: 2
FWCI
2.67
Type
journal article
Language
en
Open access
closed
Locations
  • Hormone Molecular Biology and Clinical Investigation (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Estrogen and related hormone effects
Keywords
dehydroepiandrosterone, vaginal administration, intracrinology, estradiol, testosterone, DHEA metabolites, estrone sulfate, postmenopausal women, vaginal atrophy, systemic exposure
MeSH terms
Adjuvants, Immunologic, Administration, Intravaginal, Adult, Aged, Androgens, Dehydroepiandrosterone, Dose-Response Relationship, Drug, Double-Blind Method, Estrogens, Female, Humans, Menopause, Middle Aged, Reference Values

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