Raloxifene

Generic Name: Raloxifene

Brand Names: Evista, Optruma, Raloxifene Teva

Drug Type: Small Molecule

Chemical Formula: C_₂₈H_₂₇NO_₄S

CAS Number: 84449-90-1

Unique Ingredient Identifier: YX9162EO3I

Background: Raloxifene is a second generation selective estrogen receptor modulator (SERM) that mediates anti-estrogenic effects on breast and uterine tissues, and estrogenic effects on bone, lipid metabolism, and blood coagulation. Exhibiting tissue-specific effects distinct from estradiol, raloxifene is the first of the benzothiophene group of antiestrogens to be labe...

Indication: Indicated for the prevention and treatment of osteoporosis in postmenopausal women, as well as prevention and treatment of corticosteroid-induced bone loss.

Indicated for the reduction in the risk of invasive breast cancer in postmenopausal women with osteoporosis or postmenopausal women with a high risk for invasive breast cancer.

Associated Conditions: Invasive Breast Cancer, Osteoporosis, Osteoporosis caused by Glucocorticoid Treatment

Associated Therapies: -

Clinical Trials

DP-R213 Pharmacokinetics Study

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: DP-R213
Drug: Raloxifene
Drug: Cholecaliferol

First Posted Date: 2016-05-05

Last Posted Date: 2016-11-01

Lead Sponsor: Alvogen Korea

Target Recruit Count: 61

Registration Number: NCT02762643

A Drug-drug Interaction Study of DP-R213

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Cholecalciferol
Drug: Raloxifene
Drug: Cholecalciferol and Raloxifene co-administration

First Posted Date: 2016-01-13

Last Posted Date: 2016-03-11

Lead Sponsor: Alvogen Korea

Target Recruit Count: 24

Registration Number: NCT02654093

Locations: 🇰🇷
Kyungbook National University Hospital, Jung-gu, Daegu, Korea, Republic of

Selective Estrogen Receptor Modulators for Women of Child-bearing Age With Schizophrenia

Phase 4

Completed

Conditions: Schizophrenia
Schizoaffective Disorder

Interventions: Drug: Placebo
Drug: Raloxifene hydrochloride

First Posted Date: 2015-02-03

Last Posted Date: 2020-01-09

Lead Sponsor: The Alfred

Target Recruit Count: 80

Registration Number: NCT02354001

Locations: 🇦🇺
Monash Alfred Psychiatry Research Centre, Melbourne, Victoria, Australia

Efficacy Study of Raloxifene to Induce Ovulation in Polycystic Ovarian Syndrome

Not Applicable

Terminated

Conditions: Polycystic Ovarian Syndrome

Interventions: Drug: Clomiphene
Drug: Raloxifene

First Posted Date: 2012-05-30

Last Posted Date: 2018-09-20

Lead Sponsor: Bruce Lessey

Target Recruit Count: 3

Registration Number: NCT01607320

Locations: 🇺🇸
Greenville Hospital System, Greenville, South Carolina, United States

Raloxifene as an Adjuvant Treatment of the Negative Symptoms of Schizophrenia in Post-menopausal Women

Phase 3

Completed

Conditions: Schizophrenia in Post Menopausal Women

Interventions: Drug: Lactosa (placebo arm)
Drug: Raloxifene

First Posted Date: 2012-04-09

Last Posted Date: 2024-04-22

Lead Sponsor: Fundació Sant Joan de Déu

Target Recruit Count: 78

Registration Number: NCT01573637

Locations: 🇪🇸
Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, Barcelona, Spain
🇪🇸
Corporació Sanitària Parc Taulí, Sabadell, Barcelona, Spain
🇪🇸
Hospital Psiquiàtric Institut Pere Mata, Reus, Tarragona, Spain

Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis

Phase 4

Completed

Conditions: Postmenopausal Osteoporosis
Compliance

Interventions: Drug: Strontium ranelate
Drug: Raloxifene

First Posted Date: 2012-03-06

Last Posted Date: 2012-09-03

Lead Sponsor: University of Valencia

Target Recruit Count: 80

Registration Number: NCT01544894

Locations: 🇪🇸
Hospital Universitario Dr Peset, Valencia, Spain

Selective Estrogen Receptor Modulators (SERMs) - A Potential Treatment for Psychotic Symptoms of Schizophrenia in Men?

Phase 4

Completed

Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder

Interventions: Drug: Raloxifene Hydrochloride
Drug: Placebo

First Posted Date: 2011-11-30

Last Posted Date: 2023-11-28

Lead Sponsor: The Alfred

Target Recruit Count: 13

Registration Number: NCT01481883

Locations: 🇦🇺
Alfred Hospital, Melbourne, Victoria, Australia

Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)

Completed

Conditions: Osteoporosis, Postmenopausal

Interventions: Drug: Bazedoxifene
Drug: Bisphosphonate
Drug: Raloxifene

First Posted Date: 2011-08-12

Last Posted Date: 2024-04-22

Lead Sponsor: Pfizer

Target Recruit Count: 10497

Registration Number: NCT01416194

Raloxifene in Treatment of Schizophrenia and Schizoaffective Disorder

Phase 3

Conditions: Schizophrenia
Schizoaffective Disorder

Interventions: Drug: placebo
Drug: raloxifene

First Posted Date: 2011-01-20

Last Posted Date: 2011-01-20

Lead Sponsor: Sheba Medical Center

Target Recruit Count: 200

Registration Number: NCT01280305

Locations: 🇷🇴
Spitalul de Psihiatrie Botosani, Botosani, Romania
🇷🇴
Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia", Bucuresti, Romania
🇷🇴
Sp. Jud. "Prof. Dr.O. Fodor", Cluj-Napoca, Romania

and more 4 locations

Enhancing Osteoporosis Therapy: Can We Open the Anabolic Window?

Phase 4

Completed

Conditions: Osteoporosis

Interventions: Drug: Teriparatide
Drug: Raloxifene

First Posted Date: 2010-07-21

Last Posted Date: 2014-09-22

Lead Sponsor: University of Wisconsin, Madison

Target Recruit Count: 26

Registration Number: NCT01166958

Locations: 🇺🇸
University of Wisconsin Osteoporosis Clinical Center and Research Program, Madison, Wisconsin, United States

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