A Double-Blind, Randomized, Placebo And Active- Controlled Efficacy And Safety Study Of The Effects Of Bazedoxifene/Conjugated Estrogens Combinations On Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women

CompletadoFase 3ClinicalTrials.gov

ID: NCT00808132Tipo: INTERVENTIONALInicio: 1 de ene de 2009Fin estimado: 1 de feb de 2011

Obstetricia y Ginecología Traumatología y Ortopedia

Traducción no disponible, mostrando original

Resumen

The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 64 YearsSexo: FEMALE

Criterios de inclusión

Generally healthy, postmenopausal women, aged 40 to 64 seeking treatment for menopausal symptoms
At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels \> 40 mIU/mL
Intact Uterus

Criterios de exclusión

Use of oral estrogen, progestin, androgen, or selective estrogen receptor modulator (SERM) containing drug products within 8 weeks before screening
A history or active presence of clinically important medical disease: eg. cardiovascular disease (stroke, heart attack), chronic renal or liver disease, breast cancer, etc.

Intervenciones

drug

bazedoxifene 20 mg/ conjugated estrogens 0.45 mg

One capsule, bazedoxifene 20 mg/conjugated estrogens 0.45 mg (over-encapsulated), once a day for one year.

drug

bazedoxifene 20 mg/ conjugated estrogens 0.625 mg

One capsule, bazedoxifene 20 mg/conjugated estrogens 0.625 mg (over-encapsulated), once a day for one year.

drug

bazedoxifene 20 mg

One capsule, bazedoxifene 20 mg (over-encapsulated), once a day for one year.

drug

conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg

One capsule, conjugated estrogens 0.45 mg and medroxyprogesterone 1.5 mg (over-encapsulated), once a day for one year.

drug

Placebo

One capsule, placebo (over-encapsulated), once a day for one year.

Ubicaciones

Pfizer Investigational Site

Buenos Aires, Buenos Aires, Argentina

Pfizer Investigational Site

Caba, Buenos Aires, Argentina

Pfizer Investigational Site

Caba, Buenos Aires, Argentina

Pfizer Investigational Site

Buenos Aires, Argentina

Patrocinadores

PrincipalPfizer

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