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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01507454
First Posted: January 11, 2012
Last Update Posted: February 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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'
  • Percentage of subjects reporting 'moderate' and 'severe' vaginal symptoms

Secondary Outcome Measures:
  • Adverse events

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507454


Locations
Germany
Novo Nordisk Investigational Site
Mainz, Germany, 55127
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Stute P. Urogenitale Beschwerden und Östradioltherapie: Auswirkung einer vaginalen niedrig dosierten Östradioltherapie auf die Prävalenz und Intensität von urogenitalen Beschwerden. Gynäkologische Endokrinologie 2008; 6 (1): 48-52

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01507454     History of Changes
Other Study ID Numbers: VAG-1935
First Submitted: January 5, 2012
First Posted: January 11, 2012
Last Update Posted: February 8, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Vaginitis
Atrophic Vaginitis
Atrophy
Pathological Conditions, Anatomical
Vaginal Diseases
Genital Diseases, Female
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs