Vagifem® Used for the Treatment of Atrophic Vaginitis Due to Oestrogen Deficiency

This study is conducted in Europe. The aim of this study is to investigate the self-reported impact of Vagifem® (estradiol) treatment on urogenital discomfort in women with atrophic vaginitis due to oestrogen deficiency.

Completed

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Key information

Conditions

Menopause Postmenopausal Vaginal Atrophy

Sex eligibility

Female

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Mainz, 55127, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Atrophic vaginitis due to estrogen deficiency
Post-menopausal

Treatment and study plan

estradiol, 25 mcg

Drug

Vaginal tablets for 6-12 weeks according to product labelling

Primary outcomes

Percentage of subjects reporting vaginal symptoms occuring 'often' and 'frequently'
Percentage of subjects reporting 'moderate' and 'severe' vaginal symptoms

Secondary outcomes

Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2006
First posted: Jan 11, 2012
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