Clinical trial NCT00431132: Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis
Official title: A 12 Month, Open-label, Multi-center Trial to Investigate the Endometrial Safety of Vagifem Low Dose (10ug 17beta-estradiol Vaginal Tablet) in Postmenopausal Women With Atrophic Vaginitis Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Menopause
Postmenopausal Vaginal Atrophy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-02-05
Enrollment: 336
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Endometrial Hyperplasia Based on Histological Assessment of Endometrial Biopsies
timeFrame: Week 52
Secondary outcomes:
measure: Transvaginal Ultrasound: Endometrial Thickness
timeFrame: Week 0, week 52
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Brno
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Olomouc
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Prague 5
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Prague
country: Czech Republic
facility: Novo Nordisk Investigational Site
city: Glostrup
country: Denmark
facility: Novo Nordisk Investigational Site
city: Herlev
country: Denmark
facility: Novo Nordisk Investigational Site
city: Hillerød
country: Denmark
facility: Novo Nordisk Investigational Site
city: Roskilde
country: Denmark
facility: Novo Nordisk Investigational Site
city: Virum
country: Denmark
facility: Novo Nordisk Investigational Site
city: Århus N
country: Denmark
facility: Novo Nordisk Investigational Site
city: Espoo
country: Finland
facility: Novo Nordisk Investigational Site
city: Kuopio
country: Finland
facility: Novo Nordisk Investigational Site
city: Oulu
country: Finland
facility: Novo Nordisk Investigational Site
city: Tampere
country: Finland
facility: Novo Nordisk Investigational Site
city: Turku
country: Finland
facility: Novo Nordisk Investigational Site
city: Evry
country: France
facility: Novo Nordisk Investigational Site
city: NANTES Cedex 1
country: France
facility: Novo Nordisk Investigational Site
city: Nimes
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Paris
country: France
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Pecs
country: Hungary
facility: Novo Nordisk Investigational Site
city: Szeged
country: Hungary
facility: Novo Nordisk Investigational Site
city: Drammen
country: Norway
facility: Novo Nordisk Investigational Site
city: Hamar
country: Norway
facility: Novo Nordisk Investigational Site
city: Larvik
country: Norway
facility: Novo Nordisk Investigational Site
city: Oslo
country: Norway
facility: Novo Nordisk Investigational Site
city: Sandvika
country: Norway
facility: Novo Nordisk Investigational Site
city: Ski
country: Norway
facility: Novo Nordisk Investigational Site
city: Stavanger
country: Norway
facility: Novo Nordisk Investigational Site
city: Stavanger
country: Norway
facility: Novo Nordisk Investigational Site
city: Trondheim
country: Norway
facility: Novo Nordisk Investigational Site
city: Göteborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Göteborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Linköping
country: Sweden
facility: Novo Nordisk Investigational Site
city: Malmö
country: Sweden
facility: Novo Nordisk Investigational Site
city: Norrköping
country: Sweden
facility: Novo Nordisk Investigational Site
city: Uppsala
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.