Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

Novo Nordisk A/S309 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

309

Conditions

Menopause Postmenopausal Vaginal Atrophy

Interventions

estradiol, 10 mcgDRUG

Eligibility

Sex: FEMALEMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Postmenopausal women whose last menstruation was at least two years previously

Locations (57)

Outcomes

Primary Outcomes

Clinical symptoms

Time frame: after 12 months

Secondary Outcomes

Objective parameters (vaginal Maturation Index/Value and vaginal pH)

Hyperplasia rate

Data from ClinicalTrials.gov

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