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Mylan Estradiol System/day · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Mylan Estradiol Transdermal System 0.025 mg/day |
| 2 | ACTIVE_COMPARATOR | Climara® Transdermal System 0.025 mg/day |
| Name | Type | Description |
|---|---|---|
| Mylan Estradiol Transdermal System 0.025 mg/day | DRUG | - |
| Climara® Transdermal System 0.025 mg/day | DRUG | - |
Inclusion Criteria: 1. Age: 40-69 years. 2. Sex: Females only. 3. Weight: At least 52 kg (115 lbs) and within 30% 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 BIOA...
Mylan Estradiol System/day is a transdermal patch formulation of estradiol, a small molecule estrogen therapy. It is also known as the Mylan Estradiol Transdermal System 0.025 mg/day. The product is being developed by Viatris Inc. (ticker: VTRS) and has been studied in a Phase 1 clinical trial.
Mylan Estradiol System/day is made by Viatris Inc., which trades on the Nasdaq under the ticker VTRS. Viatris is the company responsible for developing this transdermal estradiol patch.
Mylan Estradiol System/day is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 1 program consists of one completed trial.
Mylan Estradiol System/day has been evaluated in one completed Phase 1 trial, NCT00649896, titled "Evaluation of Adhesion Quality of a New Formulation of the Mylan Estradiol Transdermal System 0.025 mg/Day and Climara Transdermal System 0.025 mg/Day." The trial enrolled 76 healthy female participants aged 40 years and older in the United States.
The Phase 1 trial NCT00649896 was a randomized, active-controlled study that compared the adhesion quality of a new formulation of the Mylan Estradiol Transdermal System 0.025 mg/day with the Climara Transdermal System 0.025 mg/day. It enrolled 76 healthy female volunteers aged 40 years and older in the United States and has been completed.