Know Cancer

or
forgot password

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


Phase 3
40 Years
64 Years
Not Enrolling
Female
Menopause, Osteoporosis

Thank you

Trial Information

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


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Incidence of Endometrial Hyperplasia and Changes in Bone Mineral Density

Outcome Time Frame:

1 Year

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3115A1-3307

NCT ID:

NCT00808132

Start Date:

January 2009

Completion Date:

February 2011

Related Keywords:

  • Menopause
  • Osteoporosis
  • Postmenopausal Women
  • Bazedoxifene/Conjugated Estrogens
  • Endometrial Hyperplasia
  • Osteoporosis
  • Osteoporosis, Postmenopausal
  • Adenoma

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteCrestview Hills, Kentucky  41017
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteRichmond, Virginia  23249
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteFlagstaff, Arizona  86001
Pfizer Investigational SiteNorth Little Rock, Arkansas  72117
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteKansas City, Kansas  66112
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteLas Vegas, Nevada  89128
Pfizer Investigational SiteSanta Fe, New Mexico  87505
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteEasley,, South Carolina  29640
Pfizer Investigational SiteFarmington, Connecticut  06030-3805
Pfizer Investigational SiteOmaha, Nebraska  68198
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteLivingston, New Jersey  07039
Pfizer Investigational SiteSalt Lake City, Utah  84112
Pfizer Investigational SiteBillings, Montana  59101
Pfizer Investigational SiteLebanon, New Hampshire  03766
Pfizer Investigational SiteLewistown, Idaho  83501
Pfizer Investigational SiteBangor, Maine  04401
Pfizer Investigational SiteBismarck, North Dakota  58503
Pfizer Investigational SiteAberdeen, South Dakota  57401
Pfizer Investigational SiteProvidence, Rhode Island  02906