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Bazedoxifene and conjugated estrogens

Phase 1

Postmenopause | Small molecule | Other |Pfizer, Inc.|Last Updated: Sep 23, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials3
Total Enrollment102

FDA Designations

No designations recorded

Clinical trial landscape

Bazedoxifene and conjugated estrogens · 3 trials · 1 indication

Phase 1 3
NCT00706225Study Evaluating Potential Drug Interaction Of Bazedoxifene & Premarin In Healthy Postmenopausal WomenPostmenopause
COMPLETED30 Analytics
NCT00550433Study Evaluating Bazedoxifene/CE in Postmenopausal WomenPostmenopause
COMPLETED- Analytics
NCT00479778Study Of Pharmacokinetic (PK) Profile of Bazedoxifene (BZA) in 2 BZA/Conjugated Estrogen FormsPostmenopause
COMPLETED72 Analytics
PHASE1COMPLETED
Study Evaluating Potential Drug Interaction Of Bazedoxifene & Premarin In Healthy Postmenopausal Women
PostmenopauseUnlock trial analytics
PHASE1COMPLETED
Study Evaluating Bazedoxifene/CE in Postmenopausal Women
PostmenopauseUnlock trial analytics
PHASE1COMPLETED
Study Of Pharmacokinetic (PK) Profile of Bazedoxifene (BZA) in 2 BZA/Conjugated Estrogen Forms
PostmenopauseUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the potential pharmacokinetic (PK) interaction of multiple oral doses of bazedoxifene (BZA) and a single dose of conjugated estrogens (CE) when co administered to healthy postmenopausal women.
3 months
The plasma concentration data and pharmacokinetic (PK) parameters of BZA and CE.
Pharmacokinetic analyses.

Secondary Endpoints

To assess the safety of conjugated estrogens (CE) and bazedoxifene (BZA) when co administered to healthy postmenopausal women.
3 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALBazedoxifene and Conjugated Estrogens (BZA \& CE)

Interventions

NameTypeDescription
Bazedoxifene and conjugated estrogensDRUGBazedoxifene 20 mg tablet once daily for 7 days. Conjugated Estrogens 0.625 mg tablet, single doses one week apart.
Bazedoxifene/Conjugated EstrogensDEVICE -
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Eligibility Criteria

Age Range35 Years to 70 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy, postmenopausal woman, (either naturally or surgically and have blood hormone levels consistent with a postmenopausal state for specified subjects) between the ages of 35 and 70 years, inclusive * Have not participated in a clinical drug study for at least 30 days prio...

Countries:United States
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Frequently asked questions about Bazedoxifene and conjugated estrogens

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.