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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01507454
First received: January 5, 2012
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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
Menopause
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

  Eligibility

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

Criteria

Inclusion Criteria:

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

Locations
Germany
Mainz, Germany, 55127
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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
ClinicalTrials.gov 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:
Vaginitis
Atrophy
Vaginal Diseases
Genital Diseases, Female
Pathological Conditions, Anatomical
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014