CLINICAL TRIALS PROFILE FOR PREMPRO
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505(b)(2) Clinical Trials for PREMPRO
| 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 | 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 | >Sponsor | >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. |
| NCT00027209 ↗ | Hormone Replacement in Menopausal Women With Epilepsy | Completed | National Institute of Neurological Disorders and Stroke (NINDS) | Phase 2 | 1969-12-31 | The goal of this study is to evaluate the effect of synthetic hormone replacement therapy on anti-seizure medication levels, menopausal symptom relief, and seizure frequency and safety in menopausal women with epilepsy. |
| NCT00302731 ↗ | Bioidentical 'Natural' Hormone Evaluation in Early Menopause | Terminated | 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 | Terminated | 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. |
| NCT00302731 ↗ | Bioidentical 'Natural' Hormone Evaluation in Early Menopause | Terminated | Jeanne Drisko, MD, CNS, FACN | 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 | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for PREMPRO
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Clinical Trial Locations for PREMPRO
Trials by Country
Clinical Trial Progress for PREMPRO
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Clinical Trial Sponsors for PREMPRO
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