Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Menopause; Postmenopausal Vaginal Atrophy

Treatments: Drug: estradiol, 10 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00108849

VAG-2195

Details and patient eligibility

About

This trial is conducted in North America. The purpose of this study is to determine if Vagifem Low Dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis.

Enrollment: 309 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Postmenopausal women whose last menstruation was at least two years previously

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind