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Last Updated: November 19, 2019

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CLINICAL TRIALS PROFILE FOR PREMARIN

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505(b)(2) Clinical Trials for Premarin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00380887 Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 1 2005-06-01 The purpose of this study is to determine bioequivalence and bioavailability of four different Premarin/MPA test formulations versus the current formulation for Prempro.
New Formulation NCT00381251 Study Comparing Bioequivalence of Two New Formulations of Premarin/MPA With Premarin/MPA Reference Formulation. Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 1 2006-09-01 This study will compare the bioequivalence of two new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and medroxyprogesterone, Prempro™. Prempro is indicated for use after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The purpose of this study is to determine if these new formulations of Premarin and MPA provide the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.
New Formulation NCT00401219 Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference Formulation Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 1 2006-11-01 This study will compare the bioavailabity of three new investigational combination formulations of Premarin and medroxyprogesterone acetate (MPA) with a currently marketed formulation of Premarin and MPA, Prempro™. Prempro™ is indicated for use after menopause in women with a uterus to reduce moderate to severe hot flashes; to treat moderate to severe dryness, itching, and burning, in and around the vagina; and to help reduce your chances of getting osteoporosis (thin weak bones). The purpose of this study is to determine if these new formulations of Premarin/MPA provide the same levels of estrogen and MPA in the blood as Prempro in healthy postmenopausal women.
New Formulation NCT00472927 Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro) Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 1 2007-05-01 To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA).
New Formulation NCT00630435 Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 1 2008-02-01 The purpose of this trial is to determine the equivalence of 3 new formulations of a Premarin®/medroxyprogesterone acetate (MPA) combination tablet to the currently marketed dosage form (Prempro® [TM]). This study will be performed in healthy postmenopausal women. Each subject will participate in the study for approximately 14 weeks, including a screening evaluation within 3 weeks before the study, and four, 6-day, 5-night inpatient periods with at least a 21-day washout interval between each dose administration.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Premarin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000175 The Effects of Sex Hormones on Cognition and Mood in Older Adults Terminated National Institute on Aging (NIA) N/A 1969-12-31 This study is investigating the effects of hormone replacement therapy on memory, mental abilities and mood in older adults aged 65-90. During the nine month long study, men will take testosterone for three months and women will take estrogen for three months. At four points during the study (once every three months), participants will complete a test battery and have blood drawn.
NCT00000555 Women's Angiographic Vitamin and Estrogen Trial (WAVE) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1996-08-01 To assess whether hormonal replacement therapy and/or antioxidant treatment would stabilize or inhibit progression, and induce regression of coronary plaques. The mechanisms by which these treatments modified atherosclerosis in women were also explored.
NCT00002976 Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer Terminated Eastern Cooperative Oncology Group Phase 3 1997-06-01 RATIONALE: Estrogen replacement therapy may improve quality-of-life in postmenopausal women with endometrial cancer. It is not yet known whether estrogen replacement therapy will affect cancer recurrence. PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of estrogen replacement therapy in treating women who have stage I or stage II endometrial cancer.
NCT00002976 Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer Terminated National Cancer Institute (NCI) Phase 3 1997-06-01 RATIONALE: Estrogen replacement therapy may improve quality-of-life in postmenopausal women with endometrial cancer. It is not yet known whether estrogen replacement therapy will affect cancer recurrence. PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of estrogen replacement therapy in treating women who have stage I or stage II endometrial cancer.
NCT00002976 Estrogen Replacement Therapy in Treating Women With Early-Stage Endometrial Cancer Terminated Southwest Oncology Group Phase 3 1997-06-01 RATIONALE: Estrogen replacement therapy may improve quality-of-life in postmenopausal women with endometrial cancer. It is not yet known whether estrogen replacement therapy will affect cancer recurrence. PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of estrogen replacement therapy in treating women who have stage I or stage II endometrial cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Premarin

Condition Name

Condition Name for Premarin
Intervention Trials
Postmenopause 10
Menopause 7
Pelvic Organ Prolapse 2
Amenorrhea 2
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Condition MeSH

Condition MeSH for Premarin
Intervention Trials
Vaginitis 4
Atrophic Vaginitis 3
Arteriosclerosis 3
Ischemia 2
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Clinical Trial Locations for Premarin

Trials by Country

Trials by Country for Premarin
Location Trials
United States 127
Canada 6
Brazil 1
Japan 1
Mexico 1
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Trials by US State

Trials by US State for Premarin
Location Trials
Florida 8
Massachusetts 8
California 6
Maryland 6
Texas 5
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Clinical Trial Progress for Premarin

Clinical Trial Phase

Clinical Trial Phase for Premarin
Clinical Trial Phase Trials
Phase 4 8
Phase 3 7
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Premarin
Clinical Trial Phase Trials
Completed 34
Terminated 4
Unknown status 4
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Clinical Trial Sponsors for Premarin

Sponsor Name

Sponsor Name for Premarin
Sponsor Trials
Wyeth is now a wholly owned subsidiary of Pfizer 13
University of Washington 4
Brigham and Women's Hospital 4
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Sponsor Type

Sponsor Type for Premarin
Sponsor Trials
Other 58
Industry 22
NIH 8
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