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

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ClinicalTrials.gov Identifier: NCT01507454
Recruitment Status : Completed
First Posted : January 11, 2012
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment
Menopause Postmenopausal Vaginal Atrophy Drug: estradiol, 25 mcg

Study Type : Observational
Actual Enrollment : 1613 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vagifem® Used for the Treatment of Atrophic Vaginitis Due to Oestrogen Deficiency
Study Start Date : April 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis
U.S. FDA Resources

Group/Cohort Intervention/treatment
Local treatment Drug: estradiol, 25 mcg
Vaginal tablets for 6-12 weeks according to product labelling



Primary Outcome Measures :
  1. Percentage of subjects reporting vaginal symptoms occuring 'often' and 'frequently'
  2. Percentage of subjects reporting 'moderate' and 'severe' vaginal symptoms

Secondary Outcome Measures :
  1. Adverse events


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

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

Additional Information:
Publications of Results:
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 Posted: January 11, 2012    Key Record Dates
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