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Bazedoxifene/conjugated estrogens combination

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Dec 28, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials2
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

Bazedoxifene/conjugated estrogens combination · 2 trials · 1 indication

Phase 1 2
NCT00550303Study Comparing Formulations of Bazedoxifene/Conjugated EstrogensHealthy
COMPLETED28 Analytics
NCT00465075Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations in Fed and Fasting in Healthy, Postmenopausal WomenHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
Study Comparing Formulations of Bazedoxifene/Conjugated Estrogens
HealthyUnlock trial analytics
PHASE1COMPLETED
Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations in Fed and Fasting in Healthy, Postmenopausal Women
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioavailability
PK parameters

Secondary Endpoints

Safety & tolerability
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
bazedoxifene/conjugated estrogens combinationDRUG -
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Eligibility Criteria

Age Range45 Years to 70 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Healthy, post menopausal women ages 45 to 70 Exclusion Criteria: * Male subjects

Countries:United States
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Frequently asked questions about Bazedoxifene/conjugated estrogens combination

What is Bazedoxifene used for?

Bazedoxifene is an investigational small molecule being studied for conditions related to menopause, including postmenopausal osteoporosis, vaginal atrophy, endometrial hyperplasia, and vasomotor symptoms associated with menopause. It is being developed by Pfizer, Inc. (PFE) and is currently in Phase 3 clinical development.

Who makes Bazedoxifene?

Bazedoxifene is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. The drug is an investigational small molecule in Phase 3 clinical development for multiple menopause-related conditions, including osteoporosis and vasomotor symptoms.

What phase is Bazedoxifene in?

Bazedoxifene is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Pfizer, Inc. (PFE) is the developer, and the drug is being studied for postmenopausal osteoporosis, vaginal atrophy, and vasomotor symptoms associated with menopause.

What clinical trials has Bazedoxifene been in?

Bazedoxifene has completed three clinical trials. One Phase 3 trial (NCT00238732) evaluated Bazedoxifene with conjugated estrogens for vasomotor symptoms and vaginal atrophy in 650 women. A Phase 2 trial (NCT00238745) studied dose-response in 375 Japanese patients with postmenopausal osteoporosis. Two Phase 1 trials (NCT00479778, NCT00706225) assessed pharmacokinetics and drug interactions in healthy postmenopausal women.

Is Bazedoxifene the same as a combination therapy?

Bazedoxifene has been studied in combination with conjugated estrogens. Clinical trials such as NCT00238732 evaluated Bazedoxifene with conjugated estrogen combinations for vasomotor symptoms and vaginal atrophy, and NCT00479778 examined the pharmacokinetic profile of Bazedoxifene in two Bazedoxifene and conjugated estrogen forms.

What is the mechanism of action of Bazedoxifene?

Bazedoxifene is a small molecule being developed for menopause-related conditions. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being studied for its effects on postmenopausal osteoporosis, vaginal atrophy, and vasomotor symptoms.