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conjugated estrogens/progestin

Phase 1

Estrogen Replacement Therapy | Small molecule | Endocrine |Pfizer, Inc.|Last Updated: Dec 6, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

conjugated estrogens/progestin · 1 trial · 1 indication

Phase 1 1
NCT00401219Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference FormulationEstrogen Replacement Therapy
COMPLETED- Analytics
PHASE1COMPLETED
Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference Formulation
Estrogen Replacement TherapyUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetic blood samples for unconjugated and total (unconjugated plus conjugated) estrogens and MPA will be obtained. The following pharmacokinetic parameters will be determined: Cmax, Tmax, t½, AUC0-T, AUC0-¥.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
conjugated estrogens/progestin (MPA)DRUG -
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Eligibility Criteria

Age Range35 Years to 70 Years
SexFEMALE
Healthy VolunteersYes

Inclusion Criteria: * Healthy, postmenopausal women ages 35 to 70 years, inclusive. * Naturally postmenopausal women must not have had a menstrual period for at least six months, but less than 12 months, as confirmed by a blood test; or for at least 12 months with no blood hormone test confirmation...

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Frequently asked questions about conjugated estrogens/progestin

What is conjugated estrogens/progestin used for?

Conjugated estrogens/progestin is used for estrogen replacement therapy. It is a small molecule being developed by Pfizer, Inc. (PFE) for this endocrine condition. The drug is currently in Phase 1 clinical development as an investigational therapy.

Who makes conjugated estrogens/progestin?

Pfizer, Inc. (PFE) is the developer of conjugated estrogens/progestin. The company is conducting clinical trials to evaluate the drug for estrogen replacement therapy. The drug is currently in Phase 1 development.

What phase is conjugated estrogens/progestin in?

Conjugated estrogens/progestin is in Phase 1 clinical development. It is an investigational drug being studied for estrogen replacement therapy. The drug has completed one Phase 1 trial and is not yet approved by regulatory authorities.

What clinical trials is conjugated estrogens/progestin in?

Conjugated estrogens/progestin has one completed clinical trial, NCT00401219, titled "Study Comparing Bioavailability of 3 New Formulations of Premarin/MPA With Premarin/MPA (PREMPRO) Reference Formulation." This Phase 1 study enrolled female participants aged 35 years and older.

Is conjugated estrogens/progestin the same as Premarin/MPA?

Conjugated estrogens/progestin is being studied in a trial that compares new formulations to a reference formulation of Premarin/MPA (PREMPRO). The trial NCT00401219 evaluates the bioavailability of three new formulations against the reference product.