A 12 Month, Open-label, Multi-center Trial to Investigate the Endometrial Safety of Vagifem Low Dose (10ug 17beta-estradiol Vaginal Tablet) in Postmenopausal Women With Atrophic Vaginitis Symptoms
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies
The endometrial hyperplasia rate was calculated based on the number of patients with endometrial hyperplasia/endometrial carcinoma divided by the total number of subjects with interpretable biopsies at Week 52.
Michaela Eugster-Hausmann, MD
Novo Nordisk FemCare AG
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)