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Concentration range of serum sex steroids in normal postmenopausal women and those with diagnosis of vulvovaginal atrophy

Ke, Yuyong PhD1; Bélanger, Alain PhD2; Simard, Jean-Nicolas MSc1; Gonthier, Renaud BSc1; Martel, Céline PhD1; Vaillancourt, Mario BSc1; Labrie, Fernand MD, PhD1,2

doi: 10.1097/GME.0000000000000993
Original Articles
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Objective: The aim of the study was to determine the range of serum sex-related steroids in normal postmenopausal women and in women of the same age with a diagnosis of vulvovaginal atrophy (VVA).

Methods: Validated mass spectrometry-based assays coupled to gas or liquid chromatography were used over a 10-year period for steroid measurements. Serum samples were obtained in up to 1,512 women aged 55 to 65 years.

Results: Serum estrone sulfate (E1S) and androsterone glucuronide (ADT-G), the main metabolites of estrogens and androgens, respectively, were 16.9% (P = 0.005) and 16.1% (P = 0.001) higher in women not diagnosed with moderate/severe VVA than those diagnosed with VVA. Serum estrone (E1) was 14.5% (P < 0.0001) higher in women with no diagnosis of VVA, whereas the other steroids did not show meaningful differences. The limited biological significance of serum estradiol (E2) and testosterone is supported by the lack of statistical significance in the serum concentrations of these two steroids between the two groups. Most importantly, for the women without a diagnosis of VVA, the normal upper limit (95th centile) of serum E2 was 9.15 pg/mL (n = 364) and 10.7 pg/mL (n = 67) for a weighted average of 9.99 pg E2/mL. A limit of 10 pg E2/mL has recently been found by two other laboratories. When comparing 50- to 59-year-old and 70- to 79-year-old women, serum E2, E1S, ADT-G, and DHEA were, respectively, 24.4%, 22.6%, 27.0%, and 85.9% higher in the younger group.

Conclusions: Somewhat higher values, namely, 16.9% and 16.1%, are observed in the serum concentrations of the estrogen (E1S) and androgen (ADT-G) metabolites in normal compared with women with a diagnosis of VVA. Such data indicating a lower estrogenic and androgenic global exposure in women diagnosed with VVA offers an opportunity for the local intravaginal administration of DHEA to replace the deficiency in endogenous DHEA.

1Endoceutics, Inc., Quebec City, Canada

2Laval University, Quebec City, Canada.

Address correspondence to: Fernand Labrie, MD, PhD, Endoceutics, Inc., 2795 Laurier Boulevard, Suite 500, Quebec City, Quebec G1V 4M7, Canada. E-mail: Fernand.Labrie@endoceutics.com

Received 7 June, 2017

Revised 29 August, 2017

Accepted 29 August, 2017

Funding/support: This work was supported by Endoceutics, Inc.

Financial disclosure/conflicts of interest: FL is President/CEO of Endoceutics. YK, J-NS, RG, CM, and MV are employees of Endoceutics.

© 2018 by The North American Menopause Society.