Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00108849
First received: April 19, 2005
Last updated: October 21, 2013
Last verified: October 2013

April 19, 2005
October 21, 2013
March 2005
May 2007   (final data collection date for primary outcome measure)
Clinical symptoms [ Time Frame: after 12 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00108849 on ClinicalTrials.gov Archive Site
  • Objective parameters (vaginal Maturation Index/Value and vaginal pH) [ Designated as safety issue: No ]
  • Hyperplasia rate [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Female
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
NCT00108849
VAG-2195
No
Not Provided
Novo Nordisk A/S
Not Provided
Study Director: Alan Moses, MD Novo Nordisk A/S
Novo Nordisk A/S
October 2013

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