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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00472927 |
To evaluate three new investigational tablet formulations of the Food and Drug Administration (FDA) approved medication Prempro™, Premarin combined with medroxyprogesterone acetate (MPA).
Condition | Intervention | Phase |
---|---|---|
Postmenopause |
Drug: Premarin/MPA 0.45 mg/1.5 mg |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment |
Official Title: | An Open-Label, Single-Dose, Randomized, 4-Period, Crossover, Bioequivalence Study of Three New Formulations of Premarin 0.45mg/Medroxyprogesterone Acetate (MPA) 1.5mg Compared With a Reference Formulation of Premarin/MPA (PremproTM) 0.45mg/1.5mg in Healthy Postmenopausal Women |
Ages Eligible for Study: | 35 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 0713E1-1142 |
Study First Received: | May 10, 2007 |
Last Updated: | December 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00472927 |
Health Authority: | United States: Institutional Review Board |
Estrogens, Conjugated (USP) Medroxyprogesterone 17-Acetate Medroxyprogesterone Healthy |
Estrogens Antineoplastic Agents, Hormonal Antineoplastic Agents Contraceptive Agents Therapeutic Uses Physiological Effects of Drugs |
Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Contraceptive Agents, Male Hormones Pharmacologic Actions |