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

Completed

• Conditions: Menopause; Postmenopausal Vaginal Atrophy
• Interventions: Drug: estradiol, 25 mcg

• Registration Number: NCT01507454
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1613

Inclusion Criteria

• Atrophic vaginitis due to estrogen deficiency
• Post-menopausal

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Local treatment	estradiol, 25 mcg	-

Primary Outcome Measures

Name	Time	Method
Percentage of subjects reporting vaginal symptoms occuring 'often' and 'frequently'
Percentage of subjects reporting 'moderate' and 'severe' vaginal symptoms

Secondary Outcome Measures

Name	Time	Method
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Mainz, Germany