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Open Access 01-06-2014 | Clinical trial

Ultra-low-dose estriol and Lactobacillus acidophilus vaginal tablets (Gynoflor^®) for vaginal atrophy in postmenopausal breast cancer patients on aromatase inhibitors: pharmacokinetic, safety, and efficacy phase I clinical study

Authors: Gilbert Donders, Patrick Neven, Maximilian Moegele, Anneleen Lintermans, Gert Bellen, Valdas Prasauskas, Philipp Grob, Olaf Ortmann, Stefan Buchholz

Published in: Breast Cancer Research and Treatment | Issue 2/2014

Abstract

Phase I pharmacokinetic (PK) study assessed circulating estrogens in breast cancer (BC) patients on a non-steroidal aromatase inhibitor (NSAI) with vaginal atrophy using vaginal ultra-low-dose 0.03 mg estriol (E3) and Lactobacillus combination vaginal tablets (Gynoflor^®). 16 women on NSAI with severe vaginal atrophy applied a daily vaginal tablet of Gynoflor^® for 28 days followed by a maintenance therapy of 3 tablets weekly for 8 weeks. Primary outcomes were serum concentrations and PK of E3, estradiol (E2), and estrone (E1) using highly sensitive gas chromatography–mass spectrometry. Secondary outcomes were clinical measures for efficacy and side effects; microscopic changes in vaginal epithelium and microflora; and changes in serum FSH, LH, and sex hormone-binding globulin. Compared with baseline, serum E1 and E2 did not increase in any of the women at any time following vaginal application. Serum E3 transiently increased after the first application in 15 of 16 women, with a maximum of 168 pg/ml 2–3 h post-insertion. After 4 weeks, serum E3 was slightly increased in 8 women with a maximum of 44 pg/ml. The vaginal atrophy resolved or improved in all women. The product was well tolerated, and discontinuation of therapy was not observed. The low-dose 0.03 mg E3 and Lactobacillus acidophilus vaginal tablets application in postmenopausal BC patients during AI treatment suffering from vaginal atrophy lead to small and transient increases in serum E3, but not E1 or E2, and therefore can be considered as safe and efficacious for treatment of atrophic vaginitis in BC patients taking NSAIs.

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Title: Ultra-low-dose estriol and Lactobacillus acidophilus vaginal tablets (Gynoflor®) for vaginal atrophy in postmenopausal breast cancer patients on aromatase inhibitors: pharmacokinetic, safety, and efficacy phase I clinical study
Authors: Gilbert Donders
Patrick Neven
Maximilian Moegele
Anneleen Lintermans
Gert Bellen
Valdas Prasauskas
Philipp Grob
Olaf Ortmann
Stefan Buchholz
Publication date: 01-06-2014
Publisher: Springer US
Published in: Breast Cancer Research and Treatment / Issue 2/2014
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI: https://doi.org/10.1007/s10549-014-2930-x

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