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Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis

NCT ID: NCT00431132

Last Updated: 2017-03-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-11-30

Brief Summary

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This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.

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Detailed Description

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Conditions

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Menopause Postmenopausal Vaginal Atrophy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vagifem® 10 mcg

One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks

Group Type EXPERIMENTAL

estradiol, 10 mcg

Intervention Type DRUG

Tablets, administered intravaginally twice weekly

Interventions

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estradiol, 10 mcg

Tablets, administered intravaginally twice weekly

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women whose last menstruation was at least two years prior to the time of screening
* At least 1 urogenital symptom (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding associated with sexual activity
* Generally healthy

Exclusion Criteria

* Exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone replacement therapy) within past 3 months
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

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

Brno, , Czechia

Site Status

Novo Nordisk Investigational Site

Brno, , Czechia

Site Status

Novo Nordisk Investigational Site

Olomouc, , Czechia

Site Status

Novo Nordisk Investigational Site

Prague, , Czechia

Site Status

Novo Nordisk Investigational Site

Prague, , Czechia

Site Status

Novo Nordisk Investigational Site

Århus N, , Denmark

Site Status

Novo Nordisk Investigational Site

Glostrup Municipality, , Denmark

Site Status

Novo Nordisk Investigational Site

Herlev, , Denmark

Site Status

Novo Nordisk Investigational Site

Hillerød, , Denmark

Site Status

Novo Nordisk Investigational Site

Roskilde, , Denmark

Site Status

Novo Nordisk Investigational Site

Virum, , Denmark

Site Status

Novo Nordisk Investigational Site

Espoo, , Finland

Site Status

Novo Nordisk Investigational Site

Kuopio, , Finland

Site Status

Novo Nordisk Investigational Site

Oulu, , Finland

Site Status

Novo Nordisk Investigational Site

Tampere, , Finland

Site Status

Novo Nordisk Investigational Site

Turku, , Finland

Site Status

Novo Nordisk Investigational Site

Évry, , France

Site Status

Novo Nordisk Investigational Site

Nantes, , France

Site Status

Novo Nordisk Investigational Site

Nîmes, , France

Site Status

Novo Nordisk Investigational Site

Paris, , France

Site Status

Novo Nordisk Investigational Site

Paris, , France

Site Status

Novo Nordisk Investigational Site

Paris, , France

Site Status

Novo Nordisk Investigational Site

Budapest, , Hungary

Site Status

Novo Nordisk Investigational Site

Budapest, , Hungary

Site Status

Novo Nordisk Investigational Site

Budapest, , Hungary

Site Status

Novo Nordisk Investigational Site

Pécs, , Hungary

Site Status

Novo Nordisk Investigational Site

Szeged, , Hungary

Site Status

Novo Nordisk Investigational Site

Drammen, , Norway

Site Status

Novo Nordisk Investigational Site

Hamar, , Norway

Site Status

Novo Nordisk Investigational Site

Larvik, , Norway

Site Status

Novo Nordisk Investigational Site

Oslo, , Norway

Site Status

Novo Nordisk Investigational Site

Sandvika, , Norway

Site Status

Novo Nordisk Investigational Site

Ski, , Norway

Site Status

Novo Nordisk Investigational Site

Stavanger, , Norway

Site Status

Novo Nordisk Investigational Site

Stavanger, , Norway

Site Status

Novo Nordisk Investigational Site

Trondheim, , Norway

Site Status

Novo Nordisk Investigational Site

Gothenburg, , Sweden

Site Status

Novo Nordisk Investigational Site

Gothenburg, , Sweden

Site Status

Novo Nordisk Investigational Site

Linköping, , Sweden

Site Status

Novo Nordisk Investigational Site

Malmo, , Sweden

Site Status

Novo Nordisk Investigational Site

Norrköping, , Sweden

Site Status

Novo Nordisk Investigational Site

Uppsala, , Sweden

Site Status

Countries

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Czechia Denmark Finland France Hungary Norway Sweden

References

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Simon J, Nachtigall L, Ulrich LG, Eugster-Hausmann M, Gut R. Endometrial safety of ultra-low-dose estradiol vaginal tablets. Obstet Gynecol. 2010 Oct;116(4):876-883. doi: 10.1097/AOG.0b013e3181f386bb.

Reference Type RESULT
PMID: 20859151 (View on PubMed)

Simon J, Nachtigall L, Gut R, Lang E, Archer DF, Utian W. Effective treatment of vaginal atrophy with an ultra-low-dose estradiol vaginal tablet. Obstet Gynecol. 2008 Nov;112(5):1053-60. doi: 10.1097/AOG.0b013e31818aa7c3.

Reference Type RESULT
PMID: 18978105 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2006-001629-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VAG-1748

Identifier Type: -

Identifier Source: org_study_id

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