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Premarin reference

Phase 1

Primary Ovarian Insufficiency | Small molecule | Endocrine |Pfizer, Inc.|Last Updated: Mar 15, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

Premarin reference · 1 trial · 4 indications

Phase 1 1
NCT01436513A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.Primary Ovarian Insufficiency
COMPLETED72 Analytics
PHASE1COMPLETED
A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.
Primary Ovarian InsufficiencyUnlock trial analytics

Study Endpoints

Primary Endpoints

Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Cmax
Day 1 to Day 4
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCall
Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:Cmax
Day 1 to Day 4
Plasma unconjugated equilin pharmacokinetic parameter:AUCall
Day 1 to Day 4

Secondary Endpoints

Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:Tmax
Day 1 to Day 4
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUClast
Day 1 to Day 4
Plasma unconjugated estrone (baseline adjusted) pharmacokinetic parameter:AUCinf
Day 1 to Day 4
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
AEXPERIMENTALPremarin reference tablet as a single oral dose under fasted conditions
BEXPERIMENTALPremarin new tablet as a single oral dose under fasted conditions
CEXPERIMENTALPremarin reference tablet as a single oral dose under fed conditions
DEXPERIMENTALPremarin new tablet as a single oral dose under fed conditions

Interventions

NameTypeDescription
Premarin reference tablet (fasted)DRUGPremarin reference tablet, single dose, fasted conditions
Premarin new tablet (fasted)DRUGPremarin new tablet, single dose, fasted conditions
Premarin reference tablet (fed)DRUGPremarin reference tablet, single dose, fed conditions
Premarin new tablet (fed)DRUGPremarin new tablet, single dose, fed conditions
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Eligibility Criteria

Age Range45 Years to 75 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Japanese healthy postmenopausal women Exclusion Criteria: * History or current evidence of thrombophlebitis, thromboembolic disorders, or any coagulopathies. * History or presence of malignancy or estrogen-dependent neoplasia. Subjects with a documented history of any malign...

Countries:Japan
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Frequently asked questions about Premarin reference

What is Premarin used for?

Premarin is a small molecule drug being developed by Pfizer for use in postmenopause, primary ovarian insufficiency, and menopause. It is currently in Phase 1 clinical development, meaning it is investigational and not yet approved for these uses.

Who makes Premarin?

Premarin is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical trials for postmenopause, primary ovarian insufficiency, and menopause.

What phase is Premarin in?

Premarin is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. All three completed clinical trials for Premarin were Phase 1 studies, and there are no active trials currently ongoing.

What clinical trials is Premarin in?

Premarin has completed three Phase 1 clinical trials. These include NCT00543634, comparing Premarin with MPA, PREMPRO, and Provera in healthy postmenopausal women; NCT00630435, comparing new formulations of Premarin with a reference formulation; and NCT00745173, evaluating a potential interaction between Premarin and bazedoxifene.

Is Premarin the same as PREMPRO?

Premarin is not the same as PREMPRO, though they are related. PREMPRO is a combination product that contains Premarin (conjugated estrogens) and MPA (medroxyprogesterone acetate). Clinical trial NCT00543634 directly compared Premarin with MPA, PREMPRO, and Provera in healthy postmenopausal women.