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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR EVISTA

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Clinical Trials for Evista

Trial ID Title Status Sponsor Phase Summary
NCT00001848 The Safety and Effectiveness of Surgery With or Without Raloxifene for the Treatment of Pelvic Pain Caused by Endometriosis Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 Many women with lower abdominal pain have endometriosis. Endometriosis is a condition in which the lining of the uterus (endometrium) is found outside of the uterus. The diagnosis of endometriosis is usually made at surgery. The treatment of endometriosis includes medical and surgical approaches alone or in combination. The hormone estrogen stimulates the growth of the endometrium and may also stimulate the growth of endometriosis. Medical therapies that act to decrease the level of estrogen can reduce the amount of endometriosis and pain. When therapies are discontinued, symptoms often return. In addition, medical treatment for endometriosis is expensive and is often associated with weak bones (osteoporosis) and hot flashes as a result of low levels of estrogen. Surgical treatment is removal or destruction of the endometriosis tissue. Studies show the pain from endometriosis is relieved longer with tissue removal than with destruction. This study was developed to see if surgery followed by daily doses of Raloxifene (Evista) is effective in reducing pain, for a longer time than surgery in combination with a placebo (inactive "sugar pill") treatment. Raloxifene acts like estrogens in some tissues and not like estrogens in others. Postmenopausal women receiving Raloxifene for the prevention of osteoporosis had an increase in bone density and an improvement of their blood lipids (fat content in the blood). However, unlike estrogen, Raloxifene does not promote the growth of breast tissue or the uterus. If Raloxifene blocks estrogen action in the lining of the uterus (endometrium) of reproductive age women, as it does in post-menopausal women, it may also limit the growth of endometriosis and prevent the return of pain.
NCT00030147 Raloxifene and Rimostil for Perimenopause-Related Depression Completed National Institute of Mental Health (NIMH) Phase 4 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.
NCT00035971 EVA: Evista Alendronate Comparison Completed Eli Lilly and Company Phase 4 The purpose of this study is to determine how treatment with raloxifene compares to treatment with alendronate in postmenopausal women with osteoporosis on the chance of experiencing fractures
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Evista

Condition Name

Condition Name for Evista
Intervention Trials
Osteoporosis 5
Osteoporosis, Postmenopausal 3
Stage II Prostate Adenocarcinoma 1
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Condition MeSH

Condition MeSH for Evista
Intervention Trials
Osteoporosis 10
Osteoporosis, Postmenopausal 5
Prostatic Neoplasms 2
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Clinical Trial Locations for Evista

Trials by Country

Trials by Country for Evista
Location Trials
United States 54
Canada 12
Spain 4
Mexico 2
Austria 2
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Trials by US State

Trials by US State for Evista
Location Trials
Indiana 3
Wisconsin 3
Arizona 3
Maryland 3
California 3
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Clinical Trial Progress for Evista

Clinical Trial Phase

Clinical Trial Phase for Evista
Clinical Trial Phase Trials
Phase 4 8
Phase 3 5
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Evista
Clinical Trial Phase Trials
Completed 13
Not yet recruiting 4
Unknown status 1
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Clinical Trial Sponsors for Evista

Sponsor Name

Sponsor Name for Evista
Sponsor Trials
Eli Lilly and Company 4
Mayo Clinic 2
University of Valencia 1
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Sponsor Type

Sponsor Type for Evista
Sponsor Trials
Other 14
Industry 6
NIH 4
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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
QuintilesIMS
Mallinckrodt
Federal Trade Commission
McKesson
Cerilliant
Moodys
Johnson and Johnson
Fish and Richardson

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