Conditions: Atrophic Vaginitis
Keywords: vaginal dryness vaginal and/or vulvar irritation/itching dysuria vaginal pain and bleeding associated with sexual activity vaginal atrophy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 366
Healthy volunteers: yes

Brief summary:
The purpose of this study is to determine the therapeutic equivalence of Mylan's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment.

Detailed description:

Arms:
arm 1: Estradiol Vaginal Cream, 0.01%, administered once daily for 7 days. arm 2: Estrace® 0.01% vaginal cream, administered once daily for 7 days. arm 3: Placebo Vaginal Cream, administered once daily for 7 days.

Interventions: intervention 1: Estradiol Vaginal Cream, 0.01% intervention 2: Estrace® 0.01% cream intervention 3: Placebo Vaginal Cream
Intervention descriptions: intervention 1: Estradiol Vaginal Cream, 0.01% (1 x 2g for 7 days) intervention 2: Estrace® 0.01% vaginal cream ( 1 x 2g for 7 days) intervention 3: Placebo Vaginal Cream ( 1 x 2 g for 7 days)

Protocol document: