The purpose of this study is to evaluate the effectiveness of the drugs raloxifene and rimostil in treating perimenopause-related depression.
Perimenopause-related mood disorders cause significant distress to a large number of women; the demand for effective therapies to treat these mood disorders is considerable. Estradiol replacement therapy (ERT) has demonstrated efficacy in treating perimenopause-related depression. Unfortunately, there are long-term risks associated with ERT. Selective estrogen receptor modulators (SERMS), such as raloxifene, and phytoestrogens, such as rimostil, have estrogen-like properties and may offer a safer alternative to ERT. The effect of SERMS and phytoestrogens on mood and cognitive functioning need to be examined in women with perimenopause-related depression.
Participants in this study will undergo a medical history, physical examination, electrocardiogram (EKG), and blood and urine tests. They will then be randomly assigned to receive one of four treatments for 8 weeks: raloxifene pills plus a placebo (an inactive substance) skin patch, rimostil pills plus placebo skin patch, estradiol skin patch plus placebo pills, or placebo patch plus placebo pills. Participants will have clinic visits every 2 weeks. During the visits, blood will be drawn and participants will meet with staff members and complete symptom self-rating scales. A urine and blood sample will be collected at the beginning and end of the study. At the end of the study, participants who received placebo or whose study medication was ineffective will be offered treatment with standard antidepressant medications for 8 weeks. Non-menstruating women will receive progesterone for 10 days to induce menstrual bleeding and shedding of the inner layer of the uterus, which may have been stimulated by the study medications.

开始日期2002-02-01

申办/合作机构

National Institute of Mental Health

100 项与 Rimostil 相关的临床结果

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100 项与 Rimostil 相关的转化医学

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100 项与 Rimostil 相关的专利（医药）

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项与 Rimostil 相关的文献（医药）

2022-08-01·Neuroscience Letters

Homology modeling, virtual screening, molecular docking, molecular dynamic (MD) simulation, and ADMET approaches for identification of natural anti-Parkinson agents targeting MAO-B protein

Article

作者: Khalil, Fouad ; Ouammou, Abdelkrim ; El Aissouq, Abdellah ; Bouachrine, Mohammed

Monoamine oxidase-B (MAO-B) is a flavin-dependent enzyme involved in various neurodegenerative disorders. Here, a dataset of 142 chalcone derivatives, collected from various natural plants, was screened by combining structure-based virtual screening and ADMET approaches. The goal is to discover novel natural chalcones as potential MAO-B inhibitors. With the help of the Gaussian 09.5 software, the 3D chemical structures of compounds were optimized using the DFT method. The 3D structure of the hMAO-B enzyme was built using the Modeller software. The optimized structures were subjected to virtual screening by Autodock Vina, implicated in PyRx software. Among the 142 natural substances, 43 were selected based on their binding affinity. Then, the pharmacokinetic proprieties and toxicity of these compounds were evaluated using ADMET analysis. Ten compounds were predicted to have ADMET characteristics with no side effects. The binding modes and interactions of the top selected compounds were then evaluated using AutoDock 4.2. Compounds P60 and P81 were found to be potential inhibitors of MAO-B compared to rasagiline, safinamid, and selegiline, the reference drugs. The stability of the selected compounds was confirmed by MD simulation. Based on this finding, compounds P60 and P81 could be considered potential hMAO-B inhibitors.

2015-01-01·European Journal of Clinical Nutrition3区 · 医学

Red clover isoflavones enriched with formononetin lower serum LDL cholesterol—a randomized, double-blind, placebo-controlled study

3区 · 医学

Article

作者: Clifton-Bligh, P B ; Visvalingam, S ; Fulcher, G R ; Clifton-Bligh, R J ; Baber, R ; Nery, M-L ; Byth, K

BACKGROUNDAlthough postmenopausal combined hormone replacement therapy reduces the risk of hip fracture, long-term use may be associated with an increased risk of breast cancer, and in women more than 10 years after menopause it is associated with an increased risk of cardiovascular disease. Isoflavones, because of preferential binding to estrogen receptor beta, may retain the beneficial effects on bone but lessen the adverse effects on the breast.OBJECTIVEThe objective of this study was to study the effects of an isoflavone obtained from red clover (Rimostil) on bone mineral density, and on low-density lipoprotein (LDL) cholesterol.DESIGNIn a double-blind, randomized, placebo-controlled trial, 50 mg of Rimostil was given to women who were menopausal for at least 1 year. Bone mineral density of the spine, femoral neck and forearm and serum LDL cholesterol were measured at baseline and at 6-month intervals. The duration of follow-up was 2 years.RESULTSThere was no beneficial effect of Rimostil on bone density at any site. There was a 12% fall in serum LDL cholesterol in the Rimostil-treated arm, which was significantly greater than the 2% drop seen in the control arm (P=0.005).

2004-07-01·Maturitas3区 · 医学

Effect of isoflavones on lipids and bone turnover markers in menopausal women

3区 · 医学

Article

作者: Terri Blackwell ; Bruce Ettinger ; Kristine E Ensrud ; Jeffrey A Tice ; Tamara M Knudson Schult ; Robert Wallace

OBJECTIVESThe purpose of this analysis was to compare the effects of two dietary supplements derived from red clover to placebo on lipids and bone turnover markers in symptomatic menopausal women.METHODSThe study was a 12-week randomized, double-blind, placebo-controlled trial. Two hundred and fifty-two menopausal women ages 45-60 years experiencing > or =35 hot flashes per week were randomly assigned to Promensil (82 mg total isoflavones), Rimostil (57.2 mg total isoflavones), or placebo. Primary outcome measures were mean absolute changes for HDL-cholesterol, serum osteocalcin, and urinary N-telopeptide. Secondary outcome measures were mean changes of total cholesterol, LDL-cholesterol, the ratio of HDL- to LDL-cholesterol, and triglycerides.RESULTSNinety-eight percent of participants completed the 12-week protocol. Women taking Rimostil or Promensil compared to those taking placebo had greater mean increases in HDL-cholesterol; however, this change was small in magnitude (<2 mg/dl) and did not reach significance. There was a significant decrease in triglyceride levels among women taking Rimostil (14.4 mg/dl, P = 0.02) or Promensil (10.9 mg/dl, P = 0.05) compared to those taking placebo. The decrease was primarily among women with elevated baseline triglyceride levels (P for interaction = 0.009). There were no differences in mean changes of total cholesterol, LDL-cholesterol, or the ratio of HDL- to LDL-cholesterol among treatment groups. There were no statistically significant differences among treatment groups for bone turnover markers.CONCLUSIONSCompared with placebo, both of the supplements containing isoflavones decrease levels of triglycerides in symptomatic menopausal women; however, this effect is small in magnitude.

100 项与 Rimostil 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
心血管疾病	临床2期	澳大利亚	Novogen SAS	-
高脂血症	临床2期	澳大利亚	Novogen SAS	-
绝经期后骨质疏松	临床2期	澳大利亚	Novogen SAS	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00030147 (CTgov)	临床4期	抑郁症	65	Placebo skin patch (Placebo)	鑰餘築蓋範淵願鑰鑰窪(構衊鹽願壓窪製衊廠蓋) = 願獵艱鬱繭糧衊築蓋鏇壓壓顧鑰憲鬱壓願醖齋 (願鏇壓糧淵積鹽淵蓋壓, 簾積網選夢遞廠獵鏇鹹 ~ 壓獵襯簾壓觸鹹鏇憲鏇) 更多	-	2016-09-05
				Raloxifene (Raloxifene)	鑰餘築蓋範淵願鑰鑰窪(構衊鹽願壓窪製衊廠蓋) = 顧鹹壓糧觸築鏇網窪壓壓壓顧鑰憲鬱壓願醖齋 (願鏇壓糧淵積鹽淵蓋壓, 衊繭鹹網餘積網構築蓋 ~ 願積醖範網網繭鹹鹹選) 更多