Estriol/lactobacillus(Estriol/lactobacillus) - 药物靶点：ER_在研适应症：萎缩性阴道炎_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Estriol/Lactobacillus acidophilus、Gynoflor

靶点

ER

作用机制

ERs激动剂(雌激素受体家族激动剂)

治疗领域

泌尿生殖系统疾病

在研适应症

萎缩性阴道炎

非在研适应症-

原研机构

Medinova BV

在研机构

Medinova BV

非在研机构

Acerus Pharmaceuticals Corp.

最高研发阶段批准上市

首次获批日期

瑞士 (1986-12-18),

萎缩性阴道炎

最高研发阶段(中国)-

特殊审评-

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结构

分子式C18H24O3

InChIKeyPROQIPRRNZUXQM-ZXXIGWHRSA-N

CAS号50-27-1

关联

2

项与 Estriol/lactobacillus 相关的临床试验

NCT04044599 / Unknown statusN/AIIT

Lactobacillus for Luteal Phase Support to Improve IVF Outcomes

The aim of this study was to evaluate the effect of vaginal lactobacilli, a regulator of normal vaginal flora, on embryo implantation success during IVF / ICSI cycle follow-up.

开始日期2020-03-30

申办/合作机构

Uludag Üniversitesi

NCT02887885 / CompletedN/A

Sustainability of Vaginal Estrogen Therapy in Postmenopausal Women

Sustainability of vaginal ultra-low dose estrogen therapy in postmenopausal women

开始日期2018-01-22

申办/合作机构

Insel Gruppe AG

[+1]

100 项与 Estriol/lactobacillus 相关的临床结果

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100 项与 Estriol/lactobacillus 相关的转化医学

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100 项与 Estriol/lactobacillus 相关的专利（医药）

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10

项与 Estriol/lactobacillus 相关的文献（医药）

2015-10-01·European Journal of Clinical Microbiology & Infectious Diseases3区 · 医学

Effect of ultra-low-dose estriol and lactobacilli vaginal tablets (Gynoflor®) on inflammatory and infectious markers of the vaginal ecosystem in postmenopausal women with breast cancer on aromatase inhibitors

3区 · 医学

Article

作者: Neven, P ; Grob, P ; Bellen, G ; Donders, G ; Ortmann, O ; Buchholz, S ; Prasauskas, V

This study was a detailed microscopic analysis of the changes of vaginal microflora characteristics after application of 0.03 mg estriol-lactobacilli combination on the vaginal ecosystem in postmenopausal breast cancer (BC) survivors on aromatase inhibitors (AI) with severe atrophic vaginitis. A total of 16 BC women on AI applied daily one vaginal tablet of Gynoflor® for 28 days followed by a maintenance therapy of three tablets weekly for 8 weeks. During four follow up visits a smear from the upper lateral vaginal wall was analysed by phase contrast microscopy at 400 times magnification in order to classify the lactobacillary grades(LBG), bacterial vaginosis (BV), aerobic vaginitis (AV), vulvovaginal candidosis (VVC), proportional number of leukocytes and evidence of parabasal cells and epitheliolysis. LBG improved from 81% LBG-III at entry to 88% LBG-I&IIa after 2 weeks of initial therapy, which further improved upon follow up (p < 0.001). Whereas BV was a rare event, AV was frequent and substantially improved during treatment (p < 0.01). While at entry most patients had moderate or severe AV, after maintenance therapy no patient except one had AV. The number of leukocytes dropped dramatically from a score of 1.78 ± 0.70 to 1.06 ± 0.25 which was consistent till the end of the study (p < 0.01). Parabasal cells dropped from a score of 3.4 ± 0.64 at entry to 1.3 ± 0.60 at the final visit (p trend < 0.01). Starting from a low rate of Candida colonisation of 2/14 (14%), a sudden rise to 7/16 (44%) occurred after 2 weeks, to return back to base levels at subsequent visits. The vaginal use of ultra-low dose estriol and lactobacilli results in rapid and enduring improvement of all markers of the vaginal microflora and epithelial vaginal cell quality in women with breast cancer on AI with dyspareunia. Candida may develop soon after its use, but rapidly disappears again upon their prolonged use. Due to its excellent safety profiles and clinical efficacy we recommend this product as first choice in women on AI with severe dyspareunia.

2015-03-04·Climacteric4区 · 医学

Vaginal estriol–lactobacilli combination and quality of life in endocrine-treated breast cancer

4区 · 医学

Article

作者: M Mögele ; P Neven ; G Bellen ; G Donders ; P Grob ; S Buchholz ; A Lintermans ; V Prasauskas ; O Ortmann

OBJECTIVEWe investigated the effect of a combination of vaginal ultra-low-dose estriol with lactobacilli on the sexual functioning domain of quality of life during the treatment of breast cancer survivors on an aromatase inhibitor with vaginal atrophy.SUBJECTS AND METHODSThis was an open-label, bicentric, exploratory, clinical study in 16 postmenopausal breast cancer survivors on aromatase inhibitors suffering from vaginal atrophy-induced sexual disorders. Atrophy symptoms were assessed by scoring with an 11-point estimation scale (0 = not at all, 10 = worst imaginable feeling). Sexuality parameters of quality of life and medication adherence were recorded in a patient's diary and in the Female Somatic Sexual Experience Instrument (FSSEI) questionnaire. Patients underwent an initial treatment for 4 weeks (one vaginal tablet of Gynoflor(®) containing 0.03 mg estriol daily), followed by maintenance therapy (three vaginal Gynoflor(®) tablets weekly) for 8 weeks.RESULTSVaginal dryness continuously improved from a median score of 8 at entry to a score of 4 at the end of initial therapy, and a median score of 2 at the end of maintenance therapy. Normal sexual activity before breast cancer diagnosis was reported by 14 women (88%). At study entry, only three women (19%) were sexually active. At the end of the Gynoflor(®) regimen, ten women (63%) reported sexual activity, of which seven (44%) reported sexual intercourse. The FSSEI demonstrated a non-significant trend of improvement of parameters related to sexuality.CONCLUSIONSLocal vaginal therapy with Gynoflor(®) in breast cancer survivors on aromatase inhibitors reporting atrophic vaginitis could be considered as a useful treatment for the quality of sexual life.

2014-06-01·Breast Cancer Research and Treatment2区 · 医学

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

2区 · 医学

Article

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

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.

100 项与 Estriol/lactobacillus 相关的药物交易

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