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
  Purpose

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.


Condition Intervention Phase
Menopause
Postmenopausal Vaginal Atrophy
Drug: estradiol, 10 mcg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Clinical symptoms [ Time Frame: after 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective parameters (vaginal Maturation Index/Value and vaginal pH) [ Designated as safety issue: No ]
  • Hyperplasia rate [ Designated as safety issue: Yes ]

Enrollment: 309
Study Start Date: March 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal women whose last menstruation was at least two years previously
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108849

  Show 49 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Alan Moses, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00108849     History of Changes
Other Study ID Numbers: VAG-2195
Study First Received: April 19, 2005
Last Updated: October 21, 2013
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Additional relevant MeSH terms:
Vaginal Diseases
Genital Diseases, Female
Pathological Conditions, Anatomical
Atrophic Vaginitis
Atrophy
Vaginitis
Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014