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.

Start Date01 Feb 2002

Sponsor / Collaborator

National Institute of Mental Health

100 Clinical Results associated with Rimostil

100 Translational Medicine associated with Rimostil

100 Patents (Medical) associated with Rimostil

Literatures (Medical) associated with Rimostil

01 Aug 2022·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

Author: 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.

01 Jan 2015·European Journal of Clinical NutritionQ3 · MEDICINE

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

Q3 · MEDICINE

Article

Author: 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).

01 Jul 2004·MaturitasQ3 · MEDICINE

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

Q3 · MEDICINE

Article

Author: 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 Deals associated with Rimostil

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Cardiovascular Diseases	Phase 2	AU	Novogen SAS	-
Hyperlipidemias	Phase 2	AU	Novogen SAS	-
Osteoporosis, Postmenopausal	Phase 2	AU	Novogen SAS	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00030147 (CTgov)	Phase 4	Depressive Disorder	65	Placebo skin patch (Placebo)	jyvvlyzixg(fouddrbnwp) = rnlccmpfmk rynmfinjue (allzesvqdu, hvacfbwzib - gjocvydykm) View more	-	05 Sep 2016
				Raloxifene (Raloxifene)	jyvvlyzixg(fouddrbnwp) = qhtvrtlxoq rynmfinjue (allzesvqdu, oypwcrutda - ogxexhwgou) View more

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