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conjugated estrogens/progestin

Phase 1

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

conjugated estrogens/progestin target and mechanism

Molecular targetESR2, ESR1
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

conjugated estrogens/progestin clinical trials

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?

Conjugated estrogens/progestin is a small molecule combination therapy being developed by Pfizer for estrogen replacement therapy. It pairs conjugated estrogens with a progestin component, medroxyprogesterone acetate. The combination is designed for use in the endocrine therapeutic area and has been studied in a Phase 1 bioavailability trial.

What is conjugated estrogens/progestin used for?

Conjugated estrogens/progestin is used for estrogen replacement therapy. It combines conjugated estrogens with medroxyprogesterone acetate, a progestin, in a single regimen. The clinical program has focused on this endocrine indication, with a completed Phase 1 study conducted in healthy female volunteers aged 35 years and older.

What does conjugated estrogens/progestin target?

Conjugated estrogens/progestin targets the estrogen receptors ESR1 and ESR2 as an agonist. The estrogen component binds and activates these receptors, while the progestin component, medroxyprogesterone acetate, complements the combination. This receptor activity underlies its use in estrogen replacement therapy.

Who makes conjugated estrogens/progestin?

Pfizer, Inc. develops conjugated estrogens/progestin. Pfizer trades on the New York Stock Exchange under the ticker PFE. The company is the sponsor behind the clinical development of this conjugated estrogens and medroxyprogesterone acetate combination for estrogen replacement therapy.

What phase is conjugated estrogens/progestin in?

Conjugated estrogens/progestin is in Phase 1 development. It is an investigational combination and is not approved for marketing based on the development stage reported. One Phase 1 trial has been completed, and no active trials are currently listed for this asset.

What clinical trials is conjugated estrogens/progestin in?

Conjugated estrogens/progestin has been studied in one completed Phase 1 trial, NCT00401219. That randomized, uncontrolled study compared the bioavailability of three new formulations of Premarin/MPA against the Premarin/MPA (PREMPRO) reference formulation in healthy female volunteers aged 35 years and older, under the condition of estrogen replacement therapy.