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

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: January 5, 2012
Last updated: March 19, 2012
Last verified: March 2012

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.

Condition Intervention
Postmenopausal Vaginal Atrophy
Drug: estradiol, 25 mcg

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vagifem® Used for the Treatment of Atrophic Vaginitis Due to Oestrogen Deficiency

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Percentage of subjects reporting vaginal symptoms occuring 'often' and 'frequently' [ Designated as safety issue: No ]
  • Percentage of subjects reporting 'moderate' and 'severe' vaginal symptoms [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 1613
Study Start Date: April 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Local treatment Drug: estradiol, 25 mcg
Vaginal tablets for 6-12 weeks according to product labelling


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Women with atrophic vaginitis caused by estrogen deficiency prescribed with Vagifem® by their treating physician


Inclusion Criteria:

  • Atrophic vaginitis due to estrogen deficiency
  • Post-menopausal
  Contacts and Locations
Please refer to this study by its identifier: NCT01507454

Mainz, Germany, 55127
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Y. Kretzschmar, MD Novo Nordisk Pharma GmbH
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT01507454     History of Changes
Other Study ID Numbers: VAG-1935
Study First Received: January 5, 2012
Last Updated: March 19, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Vaginal Diseases
Genital Diseases, Female
Pathological Conditions, Anatomical
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 23, 2014