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Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00108849
First received: April 19, 2005
Last updated: February 6, 2017
Last verified: February 2017

April 19, 2005
February 6, 2017
March 2005
May 2007   (Final data collection date for primary outcome measure)
Clinical symptoms [ Time Frame: after 12 months ]
Not Provided
Complete list of historical versions of study NCT00108849 on ClinicalTrials.gov Archive Site
  • Objective parameters (vaginal Maturation Index/Value and vaginal pH)
  • Hyperplasia rate
Not Provided
Not Provided
Not Provided
 
Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms
A 12 Month Double-blind, Randomized, Parallel-group, Placebo-controlled, Multi-center Trial to Investigate the Efficacy and Safety of Vagifem Low Dose (10 mcg 17beta-estradiol Vaginal Tablet) for the Treatment of Postmenopausal Atrophic Vaginitis Symptoms
This trial is conducted in North America. The purpose of this study is to determine if Vagifem Low Dose is an effective and safe treatment for patients suffering from postmenopausal atrophic vaginitis.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
  • Menopause
  • Postmenopausal Vaginal Atrophy
Drug: estradiol, 10 mcg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
309
May 2007
May 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Postmenopausal women whose last menstruation was at least two years previously
Sexes Eligible for Study: Female
45 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
 
NCT00108849
VAG-2195
No
Not Provided
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP