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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 an investigational small molecule being studied in healthy female volunteers. It is a transdermal estradiol system delivering 0.025 mg per day. The drug is currently in Phase 1 clinical development and is not approved by the FDA.
Mylan Estradiol System/day is being developed by Viatris Inc. (NASDAQ: VTRS). The company is conducting clinical trials to evaluate this transdermal estradiol system in healthy volunteers.
Mylan Estradiol System/day is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, with no active trials currently ongoing.
Mylan Estradiol System/day has one completed clinical trial, NCT00649896. This Phase 1 study evaluated the adhesion quality of the Mylan Estradiol Transdermal System 0.025 mg/day compared to Climara Transdermal System 0.025 mg/day in 76 healthy female volunteers aged 40 years and older in the United States.
Mylan Estradiol System/day is not the same as Climara, but it was compared to Climara in a clinical trial. The study NCT00649896 evaluated the adhesion quality of the Mylan Estradiol Transdermal System 0.025 mg/day against Climara Transdermal System 0.025 mg/day in healthy female volunteers.