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NCT01507454 Clinical Trial

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

Menopause Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01507454
Other study ID # VAG-1935
Secondary ID
Status Completed
Phase N/A
First received January 5, 2012
Last updated February 6, 2017
Start date April 2006
Est. completion date November 2006

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1613
Est. completion date November 2006
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Atrophic vaginitis due to estrogen deficiency

- Post-menopausal

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• estradiol, 25 mcg
Vaginal tablets for 6-12 weeks according to product labelling

Locations
Country Name City State
Germany Novo Nordisk Investigational Site Mainz

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of subjects reporting vaginal symptoms occuring 'often' and 'frequently'
Primary Percentage of subjects reporting 'moderate' and 'severe' vaginal symptoms
Secondary Adverse events
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