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Last Updated: September 22, 2021

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CLINICAL TRIALS PROFILE FOR PREMPRO

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505(b)(2) Clinical Trials for Prempro

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).
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Prempro

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.
NCT00302731 ↗ Bioidentical 'Natural' Hormone Evaluation in Early Menopause Completed Private Foundation through KU Endowment Phase 2 2006-02-01 Prospective double blind pilot study comparing bioidentical 'natural' hormones to low-dose PremPro. Forty participants will be enrolled. The purpose of this study is to try to gather early information about safety when "natural" or bioidentical hormones are used during early menopause.
NCT00302731 ↗ Bioidentical 'Natural' Hormone Evaluation in Early Menopause Completed University of Kansas Phase 2 2006-02-01 Prospective double blind pilot study comparing bioidentical 'natural' hormones to low-dose PremPro. Forty participants will be enrolled. The purpose of this study is to try to gather early information about safety when "natural" or bioidentical hormones are used during early menopause.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Prempro

Condition Name

Condition Name for Prempro
Intervention Trials
Postmenopause 6
Menopause 4
Coronary Disease 1
Mood Disorders 1
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Condition MeSH

Condition MeSH for Prempro
Intervention Trials
Osteoporosis 2
Arteriosclerosis 1
Myocardial Ischemia 1
Mood Disorders 1
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Clinical Trial Locations for Prempro

Trials by Country

Trials by Country for Prempro
Location Trials
United States 50
Colombia 3
Argentina 2
Australia 2
New Zealand 2
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Trials by US State

Trials by US State for Prempro
Location Trials
Florida 3
Connecticut 2
Nebraska 2
Virginia 2
South Carolina 2
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Clinical Trial Progress for Prempro

Clinical Trial Phase

Clinical Trial Phase for Prempro
Clinical Trial Phase Trials
Phase 3 2
Phase 2 2
Phase 1 6
[disabled in preview] 3
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Clinical Trial Status

Clinical Trial Status for Prempro
Clinical Trial Phase Trials
Completed 12
Terminated 1
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Clinical Trial Sponsors for Prempro

Sponsor Name

Sponsor Name for Prempro
Sponsor Trials
Wyeth is now a wholly owned subsidiary of Pfizer 6
National Heart, Lung, and Blood Institute (NHLBI) 2
University of Kansas 1
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Sponsor Type

Sponsor Type for Prempro
Sponsor Trials
Industry 10
Other 5
NIH 3
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