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Estradiol System Placebo- Alternate Adhesive

Phase 1

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Apr 1, 2008

Estradiol System Placebo- Alternate Adhesive 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_CONTROLLED
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Estradiol System Placebo- Alternate Adhesive clinical trials

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
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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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Frequently asked questions about Estradiol System Placebo- Alternate Adhesive

What is Estradiol System Placebo - Alternate Adhesive?

Estradiol System Placebo - Alternate Adhesive is a placebo transdermal patch developed by Viatris Inc. (ticker VTRS). It contains no active estradiol and is used as a comparator in a clinical study evaluating the adhesion quality and skin irritation of an alternate second generation estradiol transdermal system. It is a small molecule formulation.

Who makes Estradiol System Placebo - Alternate Adhesive?

Viatris Inc., which trades under the ticker VTRS, is the developer of Estradiol System Placebo - Alternate Adhesive. The company sponsored the clinical study of this placebo patch, which was conducted in the United States.

What phase is Estradiol System Placebo - Alternate Adhesive in?

Estradiol System Placebo - Alternate Adhesive is in Phase 1 development. Its single Phase 1 trial has been completed, and no trials are currently active. The study was a randomized, placebo-controlled evaluation conducted in healthy female volunteers.

What clinical trial is Estradiol System Placebo - Alternate Adhesive in?

Estradiol System Placebo - Alternate Adhesive was evaluated in clinical trial NCT00650442, titled Evaluation of Adhesion Quality and Irritation of an Alternate Second Generation Estradiol Transdermal System. The Phase 1 trial enrolled 39 participants, was conducted in the United States, and has been completed.

Is Estradiol System Placebo - Alternate Adhesive the same as Estradiol Transdermal System Placebo - Alternate Adhesive?

Yes. Estradiol System Placebo - Alternate Adhesive is also known as Estradiol Transdermal System Placebo - Alternate Adhesive. Both names refer to the same placebo patch developed by Viatris Inc. for use as a comparator in the Phase 1 adhesion and irritation study.

Who participated in the Estradiol System Placebo - Alternate Adhesive trial?

The Phase 1 trial of Estradiol System Placebo - Alternate Adhesive enrolled 39 healthy female volunteers aged 40 years and older in the United States. The study was randomized and placebo-controlled, and it assessed adhesion quality and skin irritation of an alternate second generation estradiol transdermal system.