(Estradiol-CDS(Pharmos))-药物靶点：ER_专利_临床

概要

基本信息

药物类型

小分子化药

别名-

靶点

ER(雌激素受体家族)

作用机制

ERs激动剂(雌激素受体家族激动剂)

治疗领域

神经系统疾病、内分泌与代谢疾病

在研适应症-

非在研适应症

阿尔茨海默病、脑水肿、雌激素缺乏症状

原研机构

University of Florida

在研机构-

非在研机构

李氏大药厂控股有限公司

ImmunityBio北京盛诺基医药科技股份有限公司

最高研发阶段终止临床2期

首次获批日期(全球)-

最高研发阶段(中国)-

特殊审评-

关联

5

项与 Estradiol-CDS(Pharmos) 相关的临床试验

NCT05723523 / RecruitingN/AIIT

A Technology-Driven Intervention to Improve Early Detection and Management of Cognitive Impairment

Most experts advocate for early detection of cognitive impairment (CI) so that patients and caregivers can be prepared for making difficult decisions and to improve quality of life, but studies show that screening alone isn't sufficient to change clinician actions related to early detection. Using predictive modelling developed with machine learning methods and sophisticated clinical decision support (CDS) tools, it is possible to identify patients at elevated risk for CI and make it much easier for primary care to engage and support patients and caregivers in meaningful care planning. The goal of this study is to implement and evaluate a low-cost, highly scalable CI-CDS system integrated within the electronic health record that has high potential to improve early CI detection and care and translate massive public and private sector investments in health informatics into tangible health benefits for large numbers of people.

开始日期2023-08-23

申办/合作机构

OCHIN, Inc.

[+1]

NCT05353998 / Active, not recruitingN/AIIT

Evaluating the Efficacy of Clinical Decision Support and Sleep Navigation to Enhance Primary to Specialty Care Management of Sleep Disordered Breathing

The purpose of the study is to examine the feasibility, acceptability, and initial outcomes of clinical decision support (CDS) and a Sleep Navigation program to enhance primary to specialty care management of pediatric sleep-disordered breathing (SDB).

开始日期2022-08-01

申办/合作机构

The Children's Hospital of Philadelphia

NCT04359329 / Terminated临床2期IIT

Phase II Clinical Trial of Estradiol to Reduce Severity of COVID19 Infection in COVID19+ and Presumptive COVID19+ Patients

The purpose of this study is to find out if estrogen, a female sex hormone, given as a patch placed on skin of COVID19 positive or presumptive positive patients for 7 days can reduce the severity of COVID19 symptoms compared to regular care.
This study has two study groups. One group will receive the study drug, a single-use Climara 25cm2 estrogen patch. The other group will receive standard of care.
Participants will be asked questions about their symptoms for up 6 times in up to 45 days.

开始日期2020-04-20

申办/合作机构

Stony Brook University

100 项与 Estradiol-CDS(Pharmos) 相关的临床结果

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100 项与 Estradiol-CDS(Pharmos) 相关的专利（医药）

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23

项与 Estradiol-CDS(Pharmos) 相关的文献（医药）

2023-02-14·Menopause (New York, N.Y.)

Treating where it hurts-a randomized comparative trial of vestibule estradiol for postmenopausal dyspareunia.

Article

作者: Martha F Goetsch ; Bharti Garg ; Jen Lillemon ; Amanda L Clark

OBJECTIVE:

To compare efficacies of two strengths of estradiol cream applied to the vulvar vestibule and use of silicone lubricant to reduce intercourse pain scores in postmenopausal women with moderate/severe dyspareunia.

METHODS:

This pilot randomized comparative trial assigned 50 women to nightly applications of estradiol cream, 50 or 100 μg, for 12 weeks. We asked women to have lubricated penetration twice weekly, with intercourse or performing a tampon test. Pain, recorded in dairies, was rated using the 0-10 Numerical Rating Scale. We assessed biopsychosocial outcomes, urinary symptoms, and measured serum estradiol levels and endometrial stripe thicknesses. We performed physical examinations to determine tenderness levels of the vestibule, vagina, pelvic floor muscles, bladder, uterus, and adnexa. Comparisons were made using two-sample t test, Wilcoxon rank-sum test, or χ2/Fisher's exact test.

RESULTS:

Forty-seven women (94%), with a mean age of 59.7 years, completed the trial. The baseline median intercourse pain score was 8/10 (interquartile range, 6, 8). After 12 weeks, we measured no statistically significant difference between groups in the primary outcome, intercourse pain score, or any secondary outcome measure. For both groups together, the median intercourse pain score diminished by 50% after 4 weeks and 75% after 12 weeks (P < 0.001). The most tender anatomic area, the vulvar vestibule, improved by 82% to 100% (P < 0.001) with therapy. We did not measure a statistically significant difference in serum estradiol levels or endometrial stripe thickness between groups.

CONCLUSION:

Estradiol cream applied to the vulvar vestibule, paired with precoital silicone lubricant, is a promising alternative to vaginal therapy for dyspareunia.

2018-03-01·Journal of women's health (2002)3区 · 医学

A Randomized, Multicenter, Double-Blind, Study to Evaluate the Safety and Efficacy of Estradiol Vaginal Cream 0.003% in Postmenopausal Women with Vaginal Dryness as the Most Bothersome Symptom.

3区 · 医学

Article

作者: David F Archer ; Thomas D Kimble ; F D Yuhua Lin ; Simona Battucci ; Vilma Sniukiene ; James H Liu

BACKGROUND:

Vulvovaginal atrophy (VVA) is characterized by vaginal/vulvar dryness, irritation, dyspareunia, or dysuria. The objective of this study was to examine the efficacy and safety of a very low-dose estradiol vaginal cream (0.003%) applied twice per week in postmenopausal women with VVA-related vaginal dryness.

MATERIALS AND METHODS:

In this phase 3, randomized, double-blind, placebo-controlled, multicenter study, postmenopausal women with moderate-severe vaginal dryness as the most bothersome VVA symptom were randomized (1:1) to estradiol cream 0.003% (15 μg estradiol; 0.5 g cream) or placebo (0.5 g cream). Treatments were applied vaginally once daily for 2 weeks followed by two applications/week for 10 weeks. Coprimary outcomes were changes in severity of vaginal dryness, percentage of vaginal superficial and parabasal cells, and vaginal pH at final assessment. Additional outcomes comprised changes in severity of other VVA signs and symptoms. Adverse events (AEs) were assessed.

RESULTS:

Of the 576 randomized participants, most were white and had an average age of 59 years. At final assessment, estradiol reduced vaginal dryness severity, decreased vaginal pH, increased superficial cell percentage, and decreased parabasal cell percentage versus placebo (p ≤ 0.05, all). Estradiol also reduced vaginal dryness severity at Weeks 4-12 and dyspareunia at Week 8 versus placebo (p ≤ 0.05, all). Improvements in vaginal/vulvar irritation/itching severity and dysuria were similar between estradiol and placebo. Estradiol had comparable rates of treatment-emergent AEs to placebo. No deaths occurred.

CONCLUSIONS:

Very low-dose estradiol vaginal cream (0.003%) dosed twice weekly is an effective and well-tolerated treatment for VVA symptoms and dryness associated with menopause.

2016-08-01·Menopause (New York, N.Y.)3区 · 医学

Influence of SULT1A1 genetic variation on age at menopause, estrogen levels, and response to hormone therapy in recently postmenopausal white women.

3区 · 医学

Article

作者: Ann M Moyer ; Mariza de Andrade ; Richard M Weinshilboum ; Virginia M Miller

OBJECTIVE:

Onset and symptoms of menopause, and response to hormone therapy (HT) show large interindividual variability. SULT1A1 encodes for a highly expressed enzyme that metabolizes estrogens. We evaluated the relationship between genetic variation in SULT1A1, menopause age, symptoms, and response to HT.

METHODS:

Women enrolled in the Kronos Early Estrogen Prevention Study at Mayo Clinic were randomized to 48 months of treatment with oral conjugated equine estrogen (n = 34), transdermal 17β-estradiol (E2) (n = 33), or placebo (n = 35). Linear regression models and ANOVA were used to test for association of SULT1A1 copy number, rs3760091, rs750155, and rs9282861 (SULT1A12), with age at menopause and symptoms, levels of estrogens (estrone [E1], estrone sulfate [E1S], E2, and estradiol sulfate [E2S]), before and after HT.

RESULTS:

SULT1A1 gene copy number affected the minor allele frequency for each single nucleotide polymorphisms tested. Before administration of exogenous hormones, increasing number of G alleles at rs9282861 was associated with earlier age at menopause (P = 0.014), lower frequency of night sweats (P = 0.009), and less severe insomnia (P = 0.046). After 48 months of treatment, SULT1A1 genotype was not associated with the presence of menopausal symptoms. In women randomized to oral conjugated equine estrogen, increasing number of the A allele at rs750155 was associated with lower E1S and E2S (P = 0.004 and 0.017), whereas increasing number of the C allele at rs3760091 was associated with lower E2S/E2 (P = 0.044).

CONCLUSIONS:

Interindividual variability in onset of menopause and symptoms before initiation of HT is explained in part by genetic variation in SULT1A1 and may represent a step toward individualizing HT treatment decisions.

100 项与 Estradiol-CDS(Pharmos) 相关的药物交易

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研发状态

适应症	最高研发状态	国家/地区	公司
阿尔茨海默病	终止	美国更多	李氏大药厂控股有限公司更多
雌激素缺乏症状	终止	美国更多	ImmunityBio 更多
脑水肿	终止	美国更多	北京盛诺基医药科技股份有限公司更多

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03681691 (CTgov)	临床1期	痴呆 \| 2型糖尿病	12	Estradiol patch (Post Menopausal Women Without Diabetes)	廠膚憲觸顧製醖廠餘遞(願構構夢窪襯餘遞窪醖) = 襯廠構壓顧醖淵餘製願簾製壓積餘蓋壓齋鏇鏇 (觸壓襯選鏇積繭範鹽顧, 範遞齋壓繭壓製網夢憲 ~ 製窪積襯蓋窪醖醖製憲) 更多	-	2022-09-27
				Estradiol patch (Post Menopausal Women With Diabetes)	廠膚憲觸顧製醖廠餘遞(願構構夢窪襯餘遞窪醖) = 鬱簾鹹齋獵構鏇膚齋膚簾製壓積餘蓋壓齋鏇鏇 (觸壓襯選鏇積繭範鹽顧, 遞廠壓壓鬱醖積獵顧願 ~ 淵觸築遞顧醖壓範顧選) 更多
NCT02524561 (CTgov)	N/A	乳腺疾病	517	Placebo patch+Active Progesterone+CEE pill (CEE Pill, Active Progesterone)	鏇壓衊築餘積衊壓夢簾(遞選範願艱遞膚獵鹽糧) = 網壓遞憲鹽淵選築顧醖積選膚繭觸艱衊遞網壓 (糧襯窪醖膚膚淵獵夢膚, 鏇壓壓齋網糧壓齋鑰遞 ~ 廠鑰窪鑰齋醖衊膚鑰積) 更多	-	2017-03-08
				Placebo tablet+Active Progesterone+Estradiol patch (Estradiol Patch, Active Progesterone)	鏇壓衊築餘積衊壓夢簾(遞選範願艱遞膚獵鹽糧) = 艱範鏇襯衊鑰鏇淵廠鏇積選膚繭觸艱衊遞網壓 (糧襯窪醖膚膚淵獵夢膚, 夢鹹顧糧範鬱願獵膚願 ~ 憲艱製鑰遞網廠鹹餘範) 更多