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Vagifem Low Dose for Postmenopausal Atrophic Vaginitis Symptoms

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00108849
First Posted: April 20, 2005
Last Update Posted: February 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Objective parameters (vaginal Maturation Index/Value and vaginal pH)
  • Hyperplasia rate

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108849


  Show 57 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00108849     History of Changes
Other Study ID Numbers: VAG-2195
First Submitted: April 19, 2005
First Posted: April 20, 2005
Last Update Posted: February 8, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Vaginitis
Atrophic Vaginitis
Atrophy
Pathological Conditions, Anatomical
Vaginal Diseases
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female