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Estradiol System Placebo- Alternate Adhesive

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 1, 2008

Target and mechanism

ModalitySmall molecule

Also known as Estradiol Transdermal System Placebo - Alternate Adhesive

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

Estradiol System Placebo- Alternate Adhesive · 1 trial · 1 indication

Phase 1 1
NCT00650442Evaluation of Adhesion Quality and Irritation of an Alternate Second Generation Estradiol Transdermal SystemHealthy
COMPLETED39 Analytics
PHASE1COMPLETED
Evaluation of Adhesion Quality and Irritation of an Alternate Second Generation Estradiol Transdermal System
Healthy
NCT0065044239
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Study Endpoints

Primary Endpoints

Transdermal Adhesion
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALEstradiol Transdermal System Placebo - Alternate Adhesive
2PLACEBO_COMPARATOREstradiol Transdermal System Placebo - Current Adhesive

Interventions

NameTypeDescription
Estradiol Transdermal System Placebo - Alternate AdhesiveDRUGsingle application
Estradiol Transdermal System Placebo - Current AdhesiveDRUGsingle application
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Eligibility Criteria

Age Range40 Years to 66 Years
SexFEMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age: 40-66 years. 2. Sex: Females only. 3. Weight: At least 52 kg (115 lbs) and within 20% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" from Metropolitan Life Insurance Company, 1999 (See Part II: ADMINISTRATIVE ASPECTS OF HUMAN DE...

Countries:United States
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