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Premarin/MPA formulation A

Phase 1

Menopause | Small molecule | Endocrine |Pfizer, Inc.|Last Updated: Feb 4, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment76

FDA Designations

No designations recorded

Clinical trial landscape

Premarin/MPA formulation A · 1 trial · 1 indication

Phase 1 1
NCT00630435Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference FormulationMenopause
COMPLETED76 Analytics
PHASE1COMPLETED
Study Comparing 3 New Formulations of Premarin® 0.625 mg/MPA 2.5 mg With a Reference Formulation
Menopause
NCT0063043576
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Study Endpoints

Primary Endpoints

Plasma concentrations of Premarin® and medroxyprogesterone acetate between test and currently marketed formulations
14 weeks

Secondary Endpoints

No secondary outcome
No time frame
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Premarin®/MPA formulation ADRUG -
Premarin®/MPA formulation BDRUG -
Premarin®/MPA formulation CDRUG -
Premarin®/MPA currently marketed productDRUG -
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Eligibility Criteria

Age Range35 Years to 70 Years
SexFEMALE
Healthy VolunteersYes

Inclusion 1. Healthy postmenopausal women aged 35 to 70. 2. Body mass index of 18 to 35 kg/m2, weight must be at least 50 kg. 3. Nonsmoker or smoker of fewer than 10 cigarettes/day. Exclusion 1. History or presence of hypertension (\>139 mm Hg systolic or \>89 mm Hg diastolic). Can take up to 2 a...

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Frequently asked questions about Premarin/MPA formulation A

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.