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Premarin

Phase 1

Postmenopause | Small molecule | Other |Pfizer, Inc.|Last Updated: Jun 22, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials3
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Premarin · 3 trials · 1 indication

Phase 1 3
NCT00745173Study Evaluating Premarin and Bazedoxifene Potential InteractionPostmenopause
COMPLETED30 Analytics
NCT00543634Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal WomenPostmenopause
COMPLETED30 Analytics
NCT00472927Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)Postmenopause
COMPLETED- Analytics
PHASE1COMPLETED
Study Evaluating Premarin and Bazedoxifene Potential Interaction
PostmenopauseUnlock trial analytics
PHASE1COMPLETED
Study Comparing Premarin®/MPA, PREMPRO® and Provera® in Healthy Postmenopausal Women
PostmenopauseUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of 3 New Formulations of Premarin/MPA Compared With Premarin/MPA (Prempro)
PostmenopauseUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetic (absorption, distribution, breakdown and elimination in the body) parameters
3 months
Plasma concentration data and pharmacokinetic (PK) parameters of MPA and Premarin® (estrone, equilin and MPA).
4 days
Plasma concentration data and PK parameters of MPA and Premarin (esrone and equilin components)

Secondary Endpoints

To continue assessment of the safety profile as well as the tolerability the two drugs administered in combination in this population.
3 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1OTHER -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
PremarinDRUG -
Premarin/MPADRUG0.625 mg/2.5 mg X4
Provera 10 mgDRUG2.5 mg of MPA, 4 tablets dissoved in water
Premarin/MPA 0.45 mg/1.5 mgDRUG -
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Eligibility Criteria

Age Range35 Years to 70 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * For inclusion into the study, women must be healthy and postmenopausal (either naturally or surgically) between the ages of 35 and 70, inclusive. * Blood hormone levels must be consistent with a postmenopausal state (for specified subjects). * They can either be a non-smoker o...

Countries:United States
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Frequently asked questions about Premarin

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.