Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

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.

Completed

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Key information

Conditions

Menopause Postmenopausal Vaginal Atrophy

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Kingston, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Postmenopausal women whose last menstruation was at least two years previously

Treatment and study plan

estradiol, 10 mcg

Drug

Primary outcomes

Clinical symptoms

Time frame: after 12 months

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A 12 Month Double-blind, Randomized, Parallel-group, Placebo-controlled, Multi-center Trial to Investigate the Efficacy and Safety of Vagifem Low Dose (10 mcg 17beta-estradiol Vaginal Tablet) for the Treatment of Postmenopausal Atrophic Vaginitis Symptoms

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Apr 20, 2005
Registry last updated: Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed