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Generated: December 17, 2018

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CLINICAL TRIALS PROFILE FOR DUAVEE

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Clinical Trials for Duavee

Trial ID Title Status Sponsor Phase Summary
NCT02100553 Study Evaluating Effects of Multiple-Dose Administration of Itraconazole on the Single Dose Pharmacokinetics of Conjugated Estrogens/Bazedoxifene in Non-Obese and Obese Postmenopausal Women Completed Pfizer Phase 1 This study will assess if itraconazole will affect the blood levels of Duavee when they are given together. This study will also assess if a subject's body size affects the blood levels of Duavee.
NCT02237079 Duavee Prevention of Metabolic Dysfunction in Postmenopausal Women Unknown status Tulane University Health Sciences Center Phase 4 The goal of this pilot clinical study is to perform a randomized placebo-controlled study to assess the beneficial effect of a 3 month-treatment with DUAVEE vs. placebo on glucose homeostasis and body composition in 20 post-menopausal women. The recruitment will be performed at Tulane Health Sciences Center.
NCT02274571 Raising Insulin Sensitivity in Post Menopause Recruiting Pennington Biomedical Research Center Phase 0 The purpose of this study is to find out if a novel drug approved by the Food and Drug Administration [Duavee™, Pfizer, Inc] for treatment of postmenopausal symptoms (vaginal dryness and hot flashes) and prevention of osteoporosis also improves insulin sensitivity by decreasing body fat especially in your liver. DUAVEE™ (Conjugated Estrogens/Bazedoxifene) is a new prescription medicine that contains a mixture of estrogen (the main female hormone made by the ovaries) and bazedoxifene, which is FDA approved. For over 60 years, estrogens have been used as hormonal treatments to help manage hot flashes and help prevent postmenopausal bone loss. But in the treatment of postmenopausal women, the use of estrogens alone can increase the risk of developing cancer of the uterus. So estrogens have been traditionally paired with a progestin to decrease the risk of hyperplasia (the thickening of the lining of the uterus), which can be a precursor to cancer. DUAVEE™ uses bazedoxifene, a selective estrogen receptor modulator (SERM), in place of a progestin to help protect the uterus against thickening of the uterus that may result from estrogens alone. In this study, you will get either DUAVEE™ or the placebo (a "dummy pill" that may look like medicine but contains no active medication) first and then switch to the other pill.
NCT02694809 Conjugated Estrogens/Bazedoxifene in Treating Patients With Ductal Carcinoma in Situ Undergoing Surgery Not yet recruiting National Cancer Institute (NCI) Phase 2 The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.
NCT02694809 Conjugated Estrogens/Bazedoxifene in Treating Patients With Ductal Carcinoma in Situ Undergoing Surgery Not yet recruiting Pfizer Phase 2 The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.
NCT02694809 Conjugated Estrogens/Bazedoxifene in Treating Patients With Ductal Carcinoma in Situ Undergoing Surgery Not yet recruiting Northwestern University Phase 2 The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.
NCT02710214 A TSEC for Symptom Management in Menopausal Women With Multiple Sclerosis Recruiting National Multiple Sclerosis Society Phase 2 Duavee is a hormone receptor modulator that has been approved for the treatment of menopausal symptoms in menopausal women. The goal of this 8-week randomized, double blind, placebo controlled pilot study, is to determine whether this medication alleviates menopausal symptoms in women with MS. The investigators will secondarily determine whether addressing menopausal symptoms ameliorates MS symptoms and, on MRIs, is not triggering worsening inflammation.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Duavee

Condition Name

Condition Name for Duavee
Intervention Trials
Menopause 2
Ductal Breast Carcinoma In Situ 1
Postmenopausal 1
Breast Cancer 1
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Condition MeSH

Condition MeSH for Duavee
Intervention Trials
Breast Neoplasms 2
Carcinoma, Ductal 1
Carcinoma in Situ 1
Carcinoma 1
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Clinical Trial Locations for Duavee

Trials by Country

Trials by Country for Duavee
Location Trials
United States 9
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Trials by US State

Trials by US State for Duavee
Location Trials
California 2
Louisiana 2
Kansas 1
Massachusetts 1
Maryland 1
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Clinical Trial Progress for Duavee

Clinical Trial Phase

Clinical Trial Phase for Duavee
Clinical Trial Phase Trials
Phase 4 2
Phase 2 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Duavee
Clinical Trial Phase Trials
Recruiting 3
Unknown status 1
Completed 1
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Clinical Trial Sponsors for Duavee

Sponsor Name

Sponsor Name for Duavee
Sponsor Trials
Pfizer 3
National Cancer Institute (NCI) 1
Pennington Biomedical Research Center 1
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Sponsor Type

Sponsor Type for Duavee
Sponsor Trials
Other 6
Industry 3
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Argus Health
US Department of Justice
Dow
Federal Trade Commission
Merck
Chubb
Fish and Richardson
Deloitte

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