Estriol serum levels in new and chronic users of vaginal estriol cream: A prospective observational study.
quantitative liquid chromatography tandem mass spectrometry
serum estriol concentrations
vaginal estriol cream
Journal
Neurourology and urodynamics
ISSN: 1520-6777
Titre abrégé: Neurourol Urodyn
Pays: United States
ID NLM: 8303326
Informations de publication
Date de publication:
04 2020
04 2020
Historique:
received:
03
11
2019
accepted:
25
02
2020
pubmed:
10
4
2020
medline:
18
11
2020
entrez:
10
4
2020
Statut:
ppublish
Résumé
To quantify estriol serum concentrations in "new" and "chronic users" of topical estriol cream using quantitative liquid chromatography tandem mass spectrometry. In this singlecentre prospective observational study, postmenopausal women with urogynaecological complaints were enrolled: 40 had not used topical estriol previously ("new users") and 50 had been applying estriol cream for more than 12 weeks ("chronic users"). In "new users," serum estriol levels were measured at baseline and after 12 weeks use. Estriol cream 1 mg/g was used daily for 3 weeks, then twice weekly with applicator (group 1A) or digitally (group 1B) or three times per week digitally (group 1C). "Chronic users" applied the cream twice (n = 7) or three (n = 43) times per week. Serum samples were taken in the morning after using cream the previous night. The main outcome measures were estriol serum concentrations in "new" and "chronic users" of estriol cream. Baseline serum estriol concentrations were less than 5 pmol/L in all 40 "new users." At 12 weeks, the 12-hour serum estriol levels ranged from less than 5 to 494 pmol/L (median 22.8; Interquartile range [IQR] 9.2-108.5). Seven "new users" had levels more than 100 pmol/L. Most of the 50 "chronic users" also had 12-hour levels less than 100 pmol/L (median 15.1 pmol/L [IQR 2.7-33.9]: three had levels more than 100 pmol/L. This study reports serum estriol concentrations in a large number of "new" and "chronic users" of vaginal estriol cream, employing a novel highly sensitive and specific technique. Overall, the results are reassuring: 87% had 12-hour estriol levels less than 100 pmol/L.
Substances chimiques
Vaginal Creams, Foams, and Jellies
0
Estriol
FB33469R8E
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1137-1144Informations de copyright
© 2020 Wiley Periodicals, Inc.
Références
Cody JD, Jacobs ML, Richardson K, Moehrer B, Hextall A. Oestrogen therapy for urinary incontinence in post-menopausal women. Cochrane Database Syst Rev. 2012;10:Cd001405.
Rossouw JE, Anderson GL, Prentice RL, et al. Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-333.
van Haaften M, Donker G, Haspels A, Thijssen J. Oestrogen concentrations in plasma, endometrium, myometrium and vagina of postmenopausal women, and effects of vaginal oestriol (E3) and oestradiol (E2) applications. J Steroid Biochem. 1989;33(4a):647-653.
Mattsson LA, Cullberg G. Vaginal absorption of two estriol preparations. A comparative study in postmenopausal women. Acta Obstet Gynecol Scand. 1983;62(5):393-396.
Haspels A, Luisi M, Kicovic P. Endocrinological and clinical investigations in post-menopausal women following administration of vaginal cream containing oestriol. Mauritas. 1981;3(3-4):321-327.
Kicovic PM, Cortes-Prieto J, Milojevic S, Haspels AA, Aljinovic A. The treatment of postmenopausal vaginal atrophy with Ovestin vaginal cream or suppositories: clinical, endocrinological and safety aspects. Maturitas. 1980;2(4):275-282.
Keller PJ, Riedmann R, Fischer M, Gerber C. Oestrogens, gonadotropins and prolactin after intra-vaginal administration of oestriol in post-menopausal women. Maturitas. 1981;3(1):47-53.
Mattsson LA, Cullberg G. A clinical evaluation of treatment with estriol vaginal cream versus suppository in postmenopausal women. Acta Obstet Gynecol Scand. 1983;62(5):397-401.
Rotti K, Stevens J, Watson D, Longcope C. Estriol concentrations in plasma of normal, non-pregnant women. Steroids. 1975;25(6):807-816.
Ponzone R, Biglia N, Jacomuzzi ME, Maggiorotto F, Mariani L, Sismondi P. Vaginal oestrogen therapy after breast cancer: is it safe? Eur J Cancer (Oxford, England: 1990). 2005 Nov;41(17):2673-2681.
Weber MA, Limpens J, Roovers JP. Assessment of vaginal atrophy: a review. Int Urogynecol J. 2015 Jan;26(1):15-28.
Pschera H, Hjerpe A, Carlstrom K. Influence of the maturity of the vaginal epithelium upon the absorption of vaginally administered estradiol-17 beta and progesterone in postmenopausal women. Gynecol Obstet Invest. 1989;27(4):204-207.
Donders G, Neven P, Moegele M, et al. Ultra-low-dose estriol and Lactobacillus acidophilus vaginal tablets (Gynoflor((R))) for vaginal atrophy in postmenopausal breast cancer patients on aromatase inhibitors: pharmacokinetic, safety, and efficacy phase I clinical study. Breast Cancer Res Treat. 2014 Jun;145(2):371-379.
Delgado JL, Estevez J, Radicioni M, Loprete L, Moscoso Del Prado J, Nieto Magro C. Pharmacokinetics and preliminary efficacy of two vaginal gel formulations of ultra-low-dose estriol in postmenopausal women. Climacteric. 2016 Apr;19(2):172-180.
te West NID, Day R, Hiley B, White C,Wright M,Moore KH,Pharmacokinetics of oestriol cream using quantitative liquid chromatography tandem mass spectrometry. Abstract #392 International Continence Society Annual Meeting; 3-6 Sep 2019; Gothenburg, Sweden.