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

NCT ID: NCT01507454

Last Updated: 2017-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1613 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-30

Study Completion Date

2006-11-30

Brief Summary

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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

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Conditions

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Menopause Postmenopausal Vaginal Atrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Local treatment

estradiol, 25 mcg

Intervention Type DRUG

Vaginal tablets for 6-12 weeks according to product labelling

Interventions

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estradiol, 25 mcg

Vaginal tablets for 6-12 weeks according to product labelling

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Atrophic vaginitis due to estrogen deficiency
* Post-menopausal
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Mainz, , Germany

Site Status

Countries

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Germany

References

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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

Reference Type RESULT

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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VAG-1935

Identifier Type: -

Identifier Source: org_study_id

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