Conditions: Atrophic Vaginitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 535
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the therapeutic equivalence of Alvogen'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:
This randomized, double-blind, placebo-controlled, parallel group, multiple-site study was designed to evaluate the therapeutic efficacy and safety of a generic Estradiol Vaginal Cream USP, 0.01% (Alvogen Pine Brook LLC) compared to the FDA Reference Listed Drug (RLD), Estrace® (estradiol vaginal cream USP, 0.01%, Warner Chilcott) in patients with atrophic vaginitis. Additionally, both the Test and the RLD formulations were tested for superiority against a Placebo.

Following the 14-day screening period, patients who continued to meet the inclusion/exclusion criteria were randomized in a 2:2:1 ratio (Test: Reference: Placebo) for 7 days of treatment.

Five hundred and thirty-five (535) patients were randomized to one of the three study products as follows:

* Test: Estradiol Vaginal Cream USP, 0.01% (Alvogen Pine Brook LLC)
* Reference: Estrace® (estradiol vaginal cream USP, 0.01%) (Warner Chilcott)
* Placebo: Test product vehicle cream (Alvogen Pine Brook LLC)

Patients completed up to three clinic visits as follows:

* Visit 1 - Screening: Day -14 to Day -1
* Visit 2 - Randomization: Day 1
* Visit 3 - End of Study: Day 8, maximum Day 10

Study product was self-administered by the patient for 7 days according to the dosing instructions provided. Each patient was required to dose once daily at approximately the me of day for 7 consecutive days.

Arms:
arm 1: Estradiol Vaginal Cream arm 2: Estrace Vaginal Cream arm 3: Placebo with no active pharmaceutical ingredients. Topical vaginal cream

Interventions: intervention 1: Estradiol intervention 2: Placebos intervention 3: Reference
Intervention descriptions: intervention 1: Estradiol Vaginal Cream intervention 2: Placebo with no active pharmaceutical ingredients. Topical vaginal cream intervention 3: Estrace Vaginal Cream

Protocol document: