Phase 3CompletedAge-related condition
A Study Comparing Estradiol Vaginal Cream to Estrace® Cream in Females With Atrophic Vaginitis
Clinical Endpoint Therapeutic Equivalence Multi-Site Study Comparing Estradiol Vaginal Cream (0.01%; Alvogen Pine Brook LLC.) to Estrace® Cream (0.01%; Warner Chilcott) in Postmenopausal Females With Atrophic Vaginitis
- Sponsor
- Alvogen Pine Brook LLC (Industry)
- Enrollment
- 535 enrolled
- Conditions
- Atrophic Vaginitis
- Interventions
- Estradiol; Placebos; Reference
- Ages
- adults, older adults
- Registry
- NCT02995694
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Vaginal Cytology
History
Results first posted
Last registry update
Registered
Primary completion
Started